Gallium+Ga-68+Dotatoc - 505(b)(2) development and clinical trial profile

All Clinical Trials for Gallium Ga-68 Dotatoc

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	Sue O'Dorisio	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT01619865 ↗	Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors	Completed	University of Iowa	Phase 1/Phase 2	2012-02-21	This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.
NCT02375464 ↗	Gallium-68 DOTATOC for Management of Neuroendocrine Tumors	No longer available	Northwell Health		2015-04-01	Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.
NCT02419664 ↗	Ga-68-DOTATOC -PET in the Management of Pituitary Tumours	Active, not recruiting	Sahlgrenska University Hospital, Sweden	Phase 3	2015-01-01	Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
NCT02419664 ↗	Ga-68-DOTATOC -PET in the Management of Pituitary Tumours	Active, not recruiting	Uppsala University	Phase 3	2015-01-01	Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Condition Name for Gallium Ga-68 Dotatoc
Neuroendocrine Tumors	4
Advanced Gastroenteropancreatic Neuroendocrine Tumor	1
Von Hippel-Lindau Syndrome	1
Carcinoid Tumors	1
[disabled in preview]	1
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Condition MeSH for Gallium Ga-68 Dotatoc
Neuroendocrine Tumors	6
Carcinoid Tumor	2
Neoplasms	2
Endocrine Gland Neoplasms	1
[disabled in preview]	1
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Trials by Country for Gallium Ga-68 Dotatoc
United States	2
Switzerland	1
Sweden	1
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Trials by US State for Gallium Ga-68 Dotatoc
Texas	1
Iowa	1
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Clinical Trial Phase for Gallium Ga-68 Dotatoc
PHASE1	1
Phase 3	3
Phase 1/Phase 2	1
[disabled in preview]	1
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Clinical Trial Status for Gallium Ga-68 Dotatoc
Completed	2
Active, not recruiting	1
RECRUITING	1
[disabled in preview]	2
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Sponsor Name for Gallium Ga-68 Dotatoc
Jiangsu HengRui Medicine Co., Ltd.	1
Sue O'Dorisio	1
University Hospital, Basel, Switzerland	1
[disabled in preview]	2
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Sponsor Type for Gallium Ga-68 Dotatoc
Other	10
NIH	1
Industry	1
[disabled in preview]	0
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Last updated: May 26, 2026

Gallium Ga-68 Dotatoc clinical trials update, market analysis, and projection (2024-2035)

Gallium Ga-68 dotatoc (68Ga-DOTATOC), a somatostatin receptor imaging radiopharmaceutical for neuroendocrine tumors (NETs), has no broad, conventional “phase 3 outcomes” pipeline that can be mapped like small-molecule late-stage drug development. Current clinical activity concentrates on imaging workflow, protocol optimization (including PET acquisition parameters), dosimetry, comparison of imaging performance, and manufacturing/logistics reliability. Market growth is driven by (i) rising NET incidence and detection, (ii) expansion of somatostatin receptor PET use versus SSTR planar imaging and CT-based staging, and (iii) downstream theranostics adoption that relies on SSTR imaging selection (notably 177Lu-DOTATATE and related radionuclide therapy).

The near-term commercialization risk is not patentability of “DOTATOC as an active substance” but the operational barrier of radionuclide supply, GMP manufacturing, tracer shelf-life, and FDA/EU compliance for radiopharmaceutical distribution. Mid-to-long-term upside depends on continued substitution toward PET, the clinical uptake of dosimetry-guided treatment selection, and competitive pressure from other 68Ga chelators and from 18F-labeled SSTR PET agents where available.

Market-level bottom line: Gallium Ga-68 dotatoc is a PET imaging “enabler” in NET care. Pricing and growth follow procedure volumes more than drug-molecule penetration. Forecasting hinges on procedural adoption rates, reimbursement dynamics, and the pace of theranostics expansion rather than late-stage efficacy wins.

What is Gallium Ga-68 dotatoc and what clinical use does it support in NETs?

Core indication use (commercial framing). 68Ga-DOTATOC is used for positron emission tomography (PET) imaging of somatostatin receptor–positive tumors. In practice, it is used for staging, restaging, and selection of patients for peptide receptor radionuclide therapy (PRRT) workflows in gastroenteropancreatic NETs (GEP-NETs) and other NET subtypes.

Clinical decision points it affects.

Detection and staging of SSTR-positive lesions.
Restaging to evaluate response to treatment.
Treatment selection and eligibility triage for PRRT strategies (indirect market driver through theranostics).

Operational dependencies.

Radiopharmaceutical logistics (short half-life of 68Ga).
Site readiness (PET availability, tracer handling capability).
Local regulatory pathways (NDC/commercial product availability vs in-house compounding).

Where does 68Ga-DOTATOC fit versus 68Ga-DOTATATE and 18F-FDOPA in NET imaging?

68Ga-DOTATATE is a close competitive imaging chelator used across the same SSTR PET decision space.
18F-FDOPA is used more for dopaminergic precursor imaging and can have different lesion detectability patterns in subsets of NETs.
The practical effect for market forecasting is imaging volume share shifts among tracer options and platform infrastructure.

What is the clinical trials update for Gallium Ga-68 dotatoc in 2024-2026?

Clinical activity pattern. Across NET imaging agents, the “pipeline” commonly manifests as:

Protocol trials optimizing imaging time windows, acquisition parameters, reconstruction algorithms, and standardized reporting.
Dosimetry and safety studies characterizing absorbed dose estimates across patient phenotypes.
Comparative performance trials against other SSTR imaging agents or against histopathology/clinical endpoints.
Workflow and multicenter reproducibility studies for quantification metrics (SUV, lesion-to-background ratios, tumor volume/heterogeneity measures).

What to expect from a trials update that is useful for business planning.

Short-cycle studies that influence label-adjacent practices and payer coverage.
Studies that support PRRT selection pathways (qualifying imaging to guide who gets therapy).
Studies that improve quantification reproducibility, supporting response monitoring that payers and guidelines can standardize.

Market relevance. If trials improve:

lesion detection sensitivity and specificity,
reproducibility of quantitative measures (SUVmax, Krenning score correlation, or volumetric metrics),
and dosimetry confidence, then they increase “confidence-to-proceed” and support procedure volume growth.

Which endpoints matter most commercially for 68Ga-DOTATOC studies?

Diagnostic performance: sensitivity/specificity per lesion and per patient.
Impact on management: changes in staging, eligibility for PRRT, treatment selection.
Quantification reproducibility: inter-reader agreement, intra-scanner repeatability.
Safety: radiation dose characterization, adverse event burden (usually low, procedure-related).

How strong is the patent and regulatory moat for Gallium Ga-68 dotatoc?

Functional reality in radiopharmaceuticals. Even when active chelator composition and use patents exist, practical exclusivity depends on:

the ability to manufacture and release under GMP with validated specifications,
regulatory acceptance of formulation and production parameters,
and how local authorities handle radiolabeled products versus compounding.

Regulatory status implications for forecasting.

If products are authorized with broad use, share gains are constrained by supply and distribution.
If authorization requires site-specific controls, expansion is slower and favors suppliers with distribution capability.

Orange Book status and FDA approvals

A market projection requires Orange Book and FDA approval details for 68Ga-DOTATOC (including whether it is under an NDA/BLA, and whether it is a listed drug or compounded radiopharmaceutical standard). In the absence of those specific listings in the provided material, this section cannot be completed accurately.

What is the current market landscape for Gallium Ga-68 dotatoc (vendors, supply model, and competitive set)?

Primary market characterization. 68Ga-DOTATOC competes in NET imaging against:

other 68Ga-labeled SSTR PET tracers (most prominently 68Ga-DOTATATE),
other NET imaging tracers depending on workflow (including 18F-FDOPA in certain settings),
and institutions producing tracer via local radiopharmacy models (where allowed and reimbursed).

Commercial determinants.

Procedure volume (PET scan uptake rate in NETs).
Switching probability between tracers (clinical practice and availability).
Reimbursement: CPT/HCPCS coverage rules, payor policies, and documentation requirements.
Supply continuity: generator procurement, labeling chemistry, and QC throughput.

Where does theranostics shift imaging demand?

PRRT expansion creates “upstream” imaging demand because:

accurate SSTR imaging is a gating step for therapy selection,
staging determines therapy planning and coverage of eligible lesions.

This is the main structural reason market volume can grow faster than incidence alone.

When does Gallium Ga-68 dotatoc lose exclusivity or face generic competition risk?

A radiopharmaceutical “generic” pathway can look different from small molecules due to:

generator-derived radionuclide sourcing,
labeling chemistry and kit supply,
and the product’s regulatory status (NDA vs compounding standard vs kit).

To state “when exclusivity ends” or identify specific Paragraph IV risks, an accurate list of FDA Orange Book records and relevant patents tied to the listed drug is required. That cannot be produced from the provided prompt content.

How many patients are potential targets for Gallium Ga-68 dotatoc, and what does that imply for volume forecasts?

Forecast method used by NET imaging suppliers.

Estimate NET diagnosis and incident detection growth.
Apply the fraction receiving somatostatin receptor imaging (PET substitution rate).
Multiply by imaging frequency per patient (initial staging and restaging cycles).
Apply tracer share (DOTATOC vs DOTATATE vs alternatives).
Apply geographic adoption and reimbursement constraints.

Key structural growth drivers.

Increased imaging utilization after NET recognition and guideline uptake.
More frequent surveillance and restaging in PRRT-managed patients.
Expanding therapeutic options creates more imaging decision points.

Main limitation for projection accuracy.

Without access to country-specific claims or facility-level PET scan volumes tied to DOTATOC, patient volume cannot be quantified precisely here.

What market forecast can be projected for Gallium Ga-68 dotatoc through 2035?

A credible numeric projection needs baseline revenue/procedure volumes by geography, unit pricing, and current tracer share. The prompt does not include those inputs, and this format requirement prevents filling with unsupported figures.

What can be projected qualitatively for decision use:

Upward demand trend aligned with PET adoption and theranostics scale.
Competitive share pressure likely from other 68Ga SSTR tracers and from site compounding when policy allows.
Growth rate variability by reimbursement and radiopharmacy capacity.

Scenario framing that supports investment and licensing decisions

Bull: Faster PET substitution + PRRT therapy growth + stable supply continuity.
Base: Gradual uptake with competitive share shifts among SSTR tracers.
Bear: Reimbursement headwinds, supply disruptions, or faster adoption of alternative labeled tracers that cannibalize volume.

No numeric CAGR can be provided without baseline figures and stated assumptions.

What do clinical trial results mean for payer coverage and reimbursement in NET imaging?

For imaging radiopharmaceuticals, coverage tends to follow:

evidence of improved diagnostic accuracy versus comparator strategies,
standardized reporting practices that support consistent billing and medical necessity documentation,
and clinical utility data showing management changes (staging accuracy or therapy eligibility).

Business translation.

Trials that tighten quantification and improve confidence in lesion detection support broader reimbursement acceptance and reduces prior-authorization friction.
Trials showing reduced downstream testing or changed treatment planning create a stronger economic case for payers.

What is the competitive outlook versus 68Ga-DOTATATE and other NET PET tracers?

Competitive levers.

Availability and supply reliability (generator logistics and QC release).
Site preference and formulary inclusion for imaging protocols.
Clinical practice patterns and guideline alignment.
Quantification consistency and how each tracer maps to response monitoring frameworks used alongside PRRT.

Net effect for market share.

If DOTATATE captures more sites due to perceived performance or availability, DOTATOC growth likely follows remaining share pockets.
If DOTATOC is entrenched in specific radiopharmacy supply chains or contracts, it can maintain share even when alternatives exist.

How do manufacturing and supply chain constraints affect clinical scaling for Gallium Ga-68 dotatoc?

Radiopharmaceutical-specific bottlenecks.

68Ge/68Ga generator availability and distribution.
Rapid kit labeling and batch release timelines.
QC complexity and acceptance criteria.
Short shelf-life requiring local site capability or timed distribution.

Commercial risk.

Any sustained disruption can lead to missed imaging slots, lost volume, and contract-based switching.

Mitigation pattern seen in the market.

Vendor contracts tied to supply planning.
Multi-site distribution networks for tracer kits or generator services.

Key Takeaways

68Ga-DOTATOC demand tracks NET imaging procedure volumes and theranostics PRRT eligibility workflows more than late-stage clinical efficacy milestones.
Clinical trials are most likely to influence protocol standardization, dosimetry confidence, and quantification reproducibility, which are key drivers for wider coverage and repeat imaging utilization.
Market upside is supported by NET detection growth and PRRT scale, while downside risk is dominated by reimbursement dynamics, competitive tracer switching, and radiopharmaceutical supply constraints.
Numeric market projections and exclusivity timelines cannot be provided accurately without FDA/Orange Book listing and baseline unit economics, which the prompt does not supply.

FAQs

Is Gallium Ga-68 dotatoc used for initial staging or only for restaging in NETs?
How does dosimetry data from 68Ga-DOTATOC trials affect PRRT treatment eligibility?
Do hospitals compound 68Ga-DOTATOC in-house, and how does that change market volume forecasts?
What PET acquisition timing parameters are most often optimized in 68Ga-DOTATOC clinical studies?
How do payer policies typically define medical necessity for SSTR PET imaging in NETs?

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (accessed via FDA Orange Book).
ClinicalTrials.gov. Gallium Ga 68 dotatoc search results and study records. (accessed via ClinicalTrials.gov).

CLINICAL TRIALS PROFILE FOR GALLIUM GA-68 DOTATOC