Clinical trial · Interventional
Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers
Molecular-Guided Surgery for Pancreatic and Gastrointestinal Neuroendocrine Cancers
NCT03623984CI-TRIAL-00069469withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no partipants
Summary
Brief summary (as posted)
The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (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 |
|---|---|---|---|
| Carcinoid | Neuroendocrine Tumor | ALIAS | 0.90 |
| Neuroendocrine Carcinoma of Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium Dotatate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gallium Dotatate
- description
- All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection.
- interventionNames
- Drug: Gallium Dotatate
Primary outcomes (1)
- measure
- Comparison of intraoperative findings to preoperative PET scan findings
- timeFrame
- From initial PET scan (2-3 weeks) until completion of the surgery
- description
- PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 19 years of age and older 2. Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection 3. Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan 4. In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study. 5. ECOG performance status of 0-1 6. Negative urine pregnancy test at screening, if applicable. Exclusion Criteria: 1. Participants who are pregnant, lactating, or intending to become pregnant during the study 2. Female participants of child-bearing age who refuse a urine pregnancy test 3. Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 4. Participants who have participated in an investigational surgical, drug, or device study within the past 30 days. 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 6. Patients whose tumors do not localize on a 68Gallium-DOTATATE scan
References
Publications (0)
Data not yet available
No reference posted for this study.