NCT03604315

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description

PRIMARY OBJECTIVES: \- Evaluate fluorine F 18 fluorthanatrace (\[18F\]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly \[ADP-ribose\] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor. SECONDARY OBJECTIVES: * Evaluate the safety of \[18F\]Fluorthanatrace. * Correlate \[18F\]Fluorthanatrace uptake measures with BRCA mutation status. * Correlate \[18F\]Fluorthanatrace uptake measures with poly \[ADP-ribose\] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies. * Evaluate change in \[18F\]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation. * To confirm the variability of imaging findings from repeated \[18F\]FTT PET/CT over 1 week before treatment initiation * Determine the change in \[18F\]FluorThanatrace uptake before treatment initiation and at time of clinical progression * Correlate \[18F\]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status OUTLINE: Patients receive fluorodeoxyglucose (FDG) intravenously (IV) and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18 fluorthanatrace (\[18F\]FTT) PET/CT over 1 hour. After completion of study treatment, patients are followed up at 24 hours.

Conditions

• Breast Carcinoma
• Fallopian Tube Carcinoma
• Ovarian Carcinoma
• Primary Peritoneal Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo FDG PET/CT
PROCEDURE	Computed Tomography	Undergo \[18F\]FTT PET/CT
RADIATION	Fludeoxyglucose F-18	Given IV
RADIATION	Fluorine F 18 Fluorthanatrace	Given IV
PROCEDURE	Positron Emission Tomography	Undergo FDG PET/CT
PROCEDURE	Positron Emission Tomography	Undergo \[18F\]FTT PET/CT

Timeline

• Start date: 2018-12-18
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2018-07-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study