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

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Pancreatic Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: [18F]FluorThanatrace ([18F]FTT)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Austin Pantel, MD; Phone Number: 855-216-0098; Email: PennCancerTrials@emergingmed.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 190104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants will be ≥ 18 years of age.
• Histologically proven pancreatic adenocarcinoma. .
• Deemed to have achieved stability following ≥16 weeks of platinum based therapy, in the opinion of an investigator
• Considered a candidate for PARP inhibitor therapy, with or without additional agents, either on a clinical trial or as part of clinical care.
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

• Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: [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).	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).; Other Names: [18F] FTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	3 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Austin Pantel, MD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Estimated): March 20, 2024
• Study Completion (Estimated): March 20, 2024

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: UPCC 42217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No