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In Vivo PARP-1 Expression With 18F-FTT PET/CT in Pancreatic Cancer

NCT03492164 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-06-12

No results posted yet for this study

Summary

The investigators plan to enroll 30 evaluable patients with (1) a histological diagnosis of advanced pancreatic ductal adenocarcinoma who have demonstrated at least stable disease following ≥16 weeks of treatment with platinum-based chemotherapy and (2) who have signed consent to participate in a clinical trial that contains PARP inhibitor therapy and are anticipated to receive this treatment or (3) will receive PARP inhibitor therapy as part of their clinical care.

A pre-treatment 18F-FluorThanatrace (\[18F\]FTT) positron emission tomography/computed tomography (PET/CT) scan will be done prior to the start of treatment with a PARP inhibitor.

PET/CT imaging will be used to evaluate PARP-1 expression in sites of pancreatic cancer using the investigational radiotracer \[18F\]FTT. This is an observational study in that \[18F\]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \[18F\]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria.

Patients will undergo approximately 60 minutes of dynamic scanning starting at the time of injection of \[18F\]FTT. This procedure will be followed by a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of approximately 10 mCi (approximate range for most studies is anticipated to be 8-12 mCi) of \[18F\]FTT. Data will be collected to evaluate uptake of \[18F\]FTT in sites of pancreatic cancer, which will be compared with PARP-1 expression in tissue, when available.

All 30 evaluable patients are expected to start PARP inhibitor therapy following the \[18F\]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 24 patients (80%) will also undergo a second (optional) scan that will be performed approximately 3 weeks (± 1 week) after therapy has started. The second scan is obtained to evaluate whether the PARP inhibitor therapy decreases \[18F\]FTT uptake, which would suggest PARP blocking by the therapy.

Conditions

Interventions

DRUG

[18F]FluorThanatrace ([18F]FTT)

1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo\[cd\]azulen-6(7H)-one also known as \[18F\]FluorThanatrace or \[18F\]FTT is a positron emitting radiopharmaceutical that has been studied in animals for selective measurement of the in vivo inhibition of the PARP-1 nuclear enzyme with positron emission tomography (PET/CT).

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Austin Pantel, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2024-06-11
Completion
2024-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03492164 on ClinicalTrials.gov