PET Imaging of PARP Activity in Cancer

NCT02469129 | Unknown Early Phase 1 DMC

• 1 other identifier: 201410102
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the feasibility of using positron emission tomography (PET) imaging technology to image cancer with \[18F\]FluorThanatrace (\[18F\]FTT), a new radioactive tracer compound that has been developed that images poly(ADP-ribose) polymerase 1 (PARP-1) activity.

Conditions

Cancer

Keywords

positron emission tomography (PET) imaging; poly(ADP-ribose) polymerase 1 (PARP1); [18F]FluorThanatrace ([18F]FTT); PARP1 inhibitors; cancer treatments

Outcome Measures

Primary Outcomes (1)

• Whole body effective dose and doses to critical organs (in rems) of a 10 millicurie (mCi) injection of [18F]FTT

  This outcome measure is assessed from the [18F]FTT PET scan performed at the 1-day study visit.

Secondary Outcomes (4)

• [18F]FTT maximum standard uptake value (SUV) in tumors

  This is measured from the [18F]FTT PET scan performed at the 1-day study visit.

• Distribution volume ratio (DVR) of [18F]FTT in tumors by Logan plot analysis

  This is measured from the [18F]FTT PET scan performed at the 1-day study visit.

• PARP enzyme activity

  This is measured from the [18F]FTT PET scan performed at the 1-day study visit.

• % positive poly(ADP)ribosylated (PAR) cells by immunohistochemistry

  This is measured from the scheduled 1-day clinically-indicated biopsy or resection occurring closest to the 1-day PET scan visit for cancer patients in the Kinetic Arm.

Study Arms (2)

Dosimetry Studies Arm

EXPERIMENTAL

Twelve participants with cancer and eight healthy volunteers will be recruited first to undergo whole-body PET/CT imaging to determine the whole body dosimetry of \[18F\]FluorThanatrace.

Drug: [18F]FluorThanatrace

Kinetic Studies Arm

EXPERIMENTAL

An additional 30 participants with cancer will undergo a 1-hour dynamic scan upon injection of \[18F\]FluorThanatrace to determine the kinetics of the tracer in tumors to correlate with tissue-based markers of PARP activity and to obtain metabolite information to help determine the best quantification approach for the PET images. When possible these subjects will also undergo 18F-FDG imaging for comparison to tumor metabolism

Drug: [18F]FluorThanatrace

Interventions

[18F]FluorThanatrace DRUG

For the Dosimetry Studies, 10 mCi of \[18F\]FTT will be injected intravenously, and participants will be placed in the following groups to be imaged with PET at the specified time points: 0 minute group--image at 0 and 120 min. after tracer injection; 30 minute group--image at 30 and 150 min. after tracer injection; 60 minute group--image at 60 and 180 min. after tracer injection; and 90 minute group--image at 90 and 210 min. after tracer injection. For the Kinetic Studies, 10 mCi of \[18F\]FTT will be injected intravenously, and a 60-minute dynamic PET scan will be obtained starting at the time of injection.

Also known as: [18F]FTT

Dosimetry Studies Arm; Kinetic Studies Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 18 years of age or older.
• Healthy volunteers without history of cardiopulmonary conditions requiring any treatment or medical intervention and who are not current smokers (Dosimetry Studies Arm only).
• Patients with biopsy-proven diagnosis of head and neck squamous cell cancer (HNSCC) or any histopathologic type of lung cancer or any other type of cancer that can be treated with platinum-based chemotherapy as first-line therapy (which includes but is not limited to ovarian, gastric, and pancreatic cancers).
• At least one tumor site that is at least 1 cm in the shortest transaxial diameter by computed tomography (CT) (Kinetic Studies Arm only; disease-free participants can be enrolled in the Dosimetry Studies Arm).

You may not qualify if:

• History of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions.
• Inability to comprehend or unwillingness to follow instructions for the study procedures as called for by the protocol.
• Presence of an implanted device that is incompatible with CT scanning.
• Non-measurable disease (\< 1 cm) by CT (Kinetic Studies Arm only; disease-free participants can be enrolled in the Dosimetry Studies Arm).
• Unable to lie in the PET/CT scanner for the time required for scanning, up to 1 hour and 15 min at a time and possibly with arms raised above the head for lung imaging.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Farrokh L Dehdashti, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 11, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (1)