Cancer Clinical Trial
Official title:
Positron Emission Tomography (PET) Imaging of Poly(ADP-Ribose) Polymerase (PARP) Activity in Cancer
Verified date | December 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | July 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | [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. | ||
Secondary | 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. | ||
Secondary | PARP enzyme activity | This is measured from the [18F]FTT PET scan performed at the 1-day study visit. | ||
Secondary | % 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. |
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