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

NCT03318497 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STU 012017-029 Protocol V6
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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

Keywords

Pancreatic adenocarcinoma; 18F-FLT; FLT; Locally advanced pancreatic adenocarcinoma; Borderline resectable pancreatic adenocarcinoma; resectable pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Summed Standardized Uptake Value (SUVmax) of Lesion After 2 Cycles of Chemotherapy

  Change in FLT PET/CT SUV Max after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Max)

  Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

• Change From Baseline in SUV Peak of Lesion After 2 Cycles of Chemotherapy

  Change in FLT PET/CT SUV peak after 2 cycles of chemotherapy will be compared to baseline (pre-treatment FLT PET/CT SUV Peak)

  Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

• Change From Baseline in Proliferative Tumor Volume After 2 Cycles Chemotherapy

  Change in FLT PET/CT Proliferative tumor volume after 2 cycles of chemotherapy (compared to pre-treatment FLT PET/CT proliferative tumor volume)

  Baseline(pre-treatment), 2 cycles after starting chemotherapy (each cycle 14 days)

• 1 Year Overall Survival

  Proportion of subjects who were alive at 1 year post-treatment is assessed

  Baseline(pre-treatment), until date of first observed death, assessed up to 1 year

• 2 Year Overall Survival

  Proportion of subjects who were alive at 2 years post-treatment is assessed

  Baseline(pre-treatment), until date of first observed death, assessed up to 2 years

Secondary Outcomes (2)

• 6 Months Progression Free Survival

  Baseline (pre-treatment), until date of first observed progression, assessed up to 6 months

• 1 Year Progression Free Survival

  Baseline(pre-treatment), until date of first observed progression, assessed up to 1 year

Study Arms (1)

Diagnostic (Interim FLT PET/CT)

EXPERIMENTAL

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 * Drug: 3'-deoxy-3'-\[F-18\] fluorothymidine: \[F-18\]FLT * Other: Laboratory Biomarker Analysis * Procedure: Positron Emission Tomography

Drug: 3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

Interventions

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

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.

Also known as: FLT, 3'-deoxy-3'-[F-18] fluorothymidine

Diagnostic (Interim FLT PET/CT)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT SCAN

Diagnostic (Interim FLT PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography

Diagnostic (Interim FLT PET/CT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (Interim FLT PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

alovudine; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Kelli Key, PhD
• Organization: UT Southwestern Medical Center

Kelli.Key@UTSouthwestern.edu

214-648-8152

Study Officials

• Daniella Pinho, MD

  UT Soutwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiology

Model Details: The interim 18F FLT-PET/CT will be performed after the 2nd cycle of chemotherapy regimen, but before the commencement of 3rd cycle. Clinical Follow Up: Standard of care clinical follow-up data will be collected up to 2 years following the end of chemotherapy.

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 24, 2017
• Study Start: December 11, 2017
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)