Clinical trial · Observational
Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract
Somatostatin Receptor Expression in Poorly-Differentiated Neuroendocrine Carcinomas of the GI Tract: Analysis Using 68Ga-dotatate PET Scan
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATATE | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants receiving PET scan
- description
- Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract
- interventionNames
- Drug: 68Ga-DOTATATE
- Diagnostic Test: Positron Emission Tomography (PET) Scan
Primary outcomes (1)
- measure
- Percentage of Participants with Uniformly Positive 68Ga-dotatate PET
- timeFrame
- Up to 10 months
- description
- Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake \> liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.
Secondary outcomes (1)
- measure
- Percentage of Participants with No Uptake to Very High Uptake on PET
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female ≥ 18 years old * Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary * Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm). Exclusion Criteria: * Participants with well-differentiated neuroendocrine tumors * Participants who have undergone 68Ga-dotatate PET scan in the past * Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.
References
Publications (0)
Data not yet available