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Patients receive FDG 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 \[18F\]FTT PET/CT over 1 hour.

Computed Tomography

Fludeoxyglucose F-18

Fluorine F 18 Fluorthanatrace

Positron Emission Tomography

Lilie Lin

Lilie L. Lin, MD

Lilie L Lin

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.

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.

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

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

To determine any correlation with BRCA status, fluorine F 18 fluorthanatrace (\[18F\]FTT) uptake values (mean and SD) across patient and lesion (summing across lesions) will be summarized, by BRCA status group. Group difference will be tested using t-tests.

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and SD across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF	NCT03604315	Breast Carcinom... Fallopian Tube ... Ovarian Carcino... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Solid Neoplasm	Computed Tomogr... Computed Tomogr... Fludeoxyglucose... Fluorine F 18 F... Positron Emissi... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF	NCT03604315	Breast Carcinom... Fallopian Tube ... Ovarian Carcino... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima... Solid Neoplasm	Computed Tomogr... Computed Tomogr... Fludeoxyglucose... Fluorine F 18 F... Positron Emissi... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center

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