Clinical trial · Interventional
68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)
Safety and Efficacy Study of 68Ga-Dotatoc Positron Emission Tomography for Diagnosis for Staging, Restaging and Assessment of Response to Treatment in Somatostatin Receptor-Positive Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): compound no longer available
Summary
Brief summary (as posted)
This study plans to demonstrate the safety and efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (\[68Ga\]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid Tumors | Neuroendocrine Tumor | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATOC PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTATOC PET
- description
- patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)
- interventionNames
- Drug: 68Ga-DOTATOC PET
Primary outcomes (1)
- measure
- Change in size of lesion
- timeFrame
- baseline and 1 month
- description
- Change in size of lesion at 1 month as compared to baseline
Secondary outcomes (3)
- measure
- Incidence of new lesions
- timeFrame
- baseline and 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report. * Karnofsky performance status of ≥50 (or ECOG/WHO equivalent) * Off Sandostatin (octreotide acetate)-long acting release (LAR) \> 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging * Able to provide informed consent * At least 18 years of age Exclusion Criteria: * Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential * Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed * Medical condition uncontrolled by treatment making completion of study unlikely * Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI) * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia) * Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation
References
Publications (0)
Data not yet available