Clinical trial · Observational
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
NCT04090034CI-TRIAL-00106147PRRTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.
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 |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peptide Receptor Radionuclide Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treated w PRRT
- description
- Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.
- interventionNames
- Procedure: Peptide Receptor Radionuclide Therapy
Primary outcomes (11)
- measure
- Demographics and other patient data
- timeFrame
- 7 years from date of procedure
- description
- (such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
- measure
- Tumor specific data
- timeFrame
- 7 years from date of procedure
- description
- Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. \> 18 years of age
2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:
* Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.
* Metastatic or Locally Advanced AND Inoperable
* Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
* Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET
* Well differentiated on path - Ki67 \< 20%
* Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:
* Cr. \<1.7
* Hgb \>8
* WBC \>2K
* Plt \>75K
* Bili \< 3x normal limit
* No Octreotide within 30 days of administration.
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and sign the Informed Consent Form in English.
Exclusion Criteria:
* Do not meet the Study Inclusion Criteria laid out in section 6.3References
Publications (0)
Data not yet available
No reference posted for this study.