Clinical trial · Interventional
Imaging Study of 18F-FAC PET Scans to Assess Standard Treatment in People With Pancreatic Cancer
18F-FAC PET Imaging to Quantify Gemcitabine Tumor Drug Uptake and Biodistribution in Pancreatic Cancer Patients
NCT05141643CI-TRIAL-00125796active not recruitingEarly Phase 1ClinicalTrials.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 purpose of this study is to find out whether a pre-treatment PET scan using the experimental imaging tracer 18F-FAC can show how much of the standard chemotherapy for PDAC may be taken up by the cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with pancreatic ductal adenocarcinoma (PDAC)
- description
- Participants will have histologically-confirmed pancreatic ductal adenocarcinoma (PDAC). The experimental design of this study is to perform a single \[18F\]-FAC PET scan prior to the administration of chemotherapy with an optional second \[18F\]-FAC PET scan procedure during SOC treatment to observe changes in tumor uptake and biodistribution. Patients will be offered a second \[18F\]-FAC PET scan procedure during their SOC treatment. This second scan will be optional.
- interventionNames
- Diagnostic Test: PET Scan
Primary outcomes (1)
- measure
- Tumor drug uptake within PDAC tumors prior at pre-treatment baseline
- timeFrame
- Baseline
- description
- The primary objective of this study is to obtain preliminary data of tumor drug uptake profile, concentration and distribution within PDAC tumors prior at pre-treatment baseline
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically-confirmed (confirmed at MSKCC) PDAC * Patients must be ≥ 18 years old * Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF). * Measurable or evaluable solid disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1. * Karnofsky Performance Status ≥70%. * Life expectancy ≥3 months. * A negative serum pregnancy test, within 1 week of the procedure, if the patient is female of reproductive potential. Exclusion Criteria: * Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia). * Women who are pregnant or breast-feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.