Phase 2
N=6
Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03318497 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy — 27.45 percentage of SUV Max change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT (Drug); Computed Tomography (Procedure); Positron Emission Tomography (Procedure); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy |
27.45 | — |
| PRIMARY Change From Baseline in SUV Peak of Lesion After 2 Cycles of Chemotherapy |
— | — |
| PRIMARY Change From Baseline in Proliferative Tumor Volume After 2 Cycles Chemotherapy |
— | — |
| PRIMARY 1 Year Overall Survival |
67 | — |
| PRIMARY 2 Year Overall Survival |
33 | — |
| SECONDARY 6 Months Progression Free Survival |
40 | — |
| SECONDARY 1 Year Progression Free Survival |
40 | — |
Summary
To assess if percentage change in 18F-FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of neoadjuvant chemotherapy can predict overall survival at 1 and 2 years and progression free survival at 6 months and 1 year in patients with borderline resectable or locally advanced, pancreatic adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically confirmed pancreatic adenocarcinoma (resectable, borderline resectable or locally advanced disease at presentation) are eligible for the study.
- Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study.
- Patients must be over 18 years old and capable and willing to provide informed consent.
- Patients must have measurable disease (by RECIST 1.1 criteria)
- Patients must have an ECOG performance status of 0-3 (restricted to ECOG PS 0-2 if age >70 years).
- Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to FLT (or FDG if for research) PET/CT imaging per institution's standard of care; A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria; Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Medically stable as judged by patient's physician.
- Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to FLT are NOT eligible.
- Ability to understand and the willingness to sign a written informed consent.
- Patient must be able to lie still for a 20 to 30 minute PET/CT scan.
Exclusion Criteria
- Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study.
- Patient must NOT be pregnant or breast-feeding.
- Patients have no clinical evidence of distant metastatic disease
- Patients must not weigh more than the maximum weight limit for the table for the PET/CT scanner where the study is being performed.(>200kg or 440lbs)
Data sourced from ClinicalTrials.gov (NCT03318497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.