CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03318497
NCT03318497Phase 2Completed
CompareCT.gov

Initial Evaluation of Role of Early Interim 18F-FLT PET/CT for Outcome Prediction in Pancreatic Adenocarcinoma

University of Texas Southwestern Medical Center·interventional·Posted Oct 24, 2017·Updated Nov 8, 2022

In Brief

A Phase 2 clinical trial evaluating 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT, Computed Tomography, and 2 other interventions for Pancreatic Adenocarcinoma. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 24, 2017
Enrollment StartDec 11, 2017
Primary CompletionJun 15, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.7 years ago

Interventions

3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLTdrug

Given IV 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-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.

Computed Tomographyprocedure

Undergo PET/CT

Positron Emission Tomographyprocedure

Undergo PET/CT

Laboratory Biomarker Analysisother

Correlative studies