Status:
COMPLETED
Role of Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-F...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03318497
Start Date
December 11 2017
End Date
June 15 2021
Last Update
November 8 2022
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390