Fluorine F 18 Fluorthanatrace PET/CT for Imaging of Patients with Primary or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Status: active

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in imaging patients with ovarian, fallopian tube, or primary peritoneal cancer that is primary or has come back (recurrent). 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 help detect the activity of a certain enzyme in the body that may be related to cancer growth.

Inclusion Criteria

Participants will be >= 18 years of age
History of known or suspected solid tumor
At least one lesion >= 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, 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.

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 PARP-1 activity in tumor tissue samples in patients who undergo biopsies.

IV. Evaluate change in [18F]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation.

V. To confirm the variability of imaging findings from repeated [18F]fluorthanatrace (FTT) PET/CT over 1 week before treatment initiation.

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.

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Fluorine F 18 Fluorthanatrace PET/CT for Imaging of Patients with Primary or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

Exclusion Criteria

United States

Texas

Houston

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Fluorine F 18 Fluorthanatrace PET/CT for Imaging of Patients with Primary or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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