Houston, Texas 77030


Purpose:

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in treating patients ovarian, fallopian tube, or primary peritoneal cancer that is primary or has come back. 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.


Study summary:

PRIMARY OBJECTIVES: I. 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: I. Evaluate the safety of [18F]Fluorthanatrace. II. Correlate [18F]Fluorthanatrace uptake measures with BRCA mutation status. III. Correlate [18F]Fluorthanatrace uptake measures with poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies. IV. Evaluate change in [18F]Fluorthanatrace uptake measures after therapy. 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.


Criteria:

Inclusion Criteria: - History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment) for women only. - At least one lesion >= 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG] PET/CT). 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 < 2 weeks prior to screening as standard of care. - Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. - Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.


NCT ID:

NCT03604315


Primary Contact:

Principal Investigator
Lilie L Lin
M.D. Anderson Cancer Center

Lilie Lin
Phone: 713-563-2300
Email: lllin@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Lilie L. Lin
Phone: 713-563-2300

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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