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

Study Overview
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Brief Summary
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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
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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. 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.

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

Conditions
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Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Solid Neoplasm

Intervention / Treatment
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* Procedure: Computed Tomography
* Procedure: Computed Tomography
* Radiation: Fludeoxyglucose F-18
* Radiation: Fluorine F 18 Fluorthanatrace
* Procedure: Positron Emission Tomography
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (FDG PET/CT, [18F]FTT PET/CT)<br>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. | Procedure: Computed Tomography<br>* Undergo FDG PET/CT<br>* Other names: tomography;Procedure: Computed Tomography<br>* Undergo [18F]FTT PET/CT<br>* Other names: tomography;Radiation: Fludeoxyglucose F-18<br>* Given IV<br>* Other names: Fluorodeoxyglucose F18;Radiation: Fluorine F 18 Fluorthanatrace<br>* Given IV<br>* Other names: [18F]FTT;Procedure: Positron Emission Tomography<br>* Undergo FDG PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;Procedure: Positron Emission Tomography<br>* Undergo [18F]FTT PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography | 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. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to 4 years | 
| BRCA mutation status | 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. | Up to 4 years | 
| PARP-1 activity in tumor tissue samples | 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. | Up to 4 years | 
| Change in fluorine F 18 fluorthanatrace uptake measures after therapy |  | Baseline up to 4 years |