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

NCT03318497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-11-08

Study results available
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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.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

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

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.

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Daniella Pinho, MD · UT Soutwestern Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2021-06-15
Completion
2021-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318497 on ClinicalTrials.gov