Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

Phase 1RecruitingNCT02637934

Abramson Cancer Center at Penn Medicine35 enrolled

Overview

Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of \[18F\]FTT in gynecological cancer and compare with PARP-1 activity in tissue.

Primary Objectives • Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of \[18F\]FluorThanatrace Secondary Objectives * Evaluate the safety of \[18F\]FluorThanatrace * Correlate \[18F\]FluorThanatrace uptake measures with BRCA mutation status * Correlate \[18F\]FluorThanatrace uptake measures with PARP-1 activity in tumor. * Determine biodistribution of the radioactive investigational drug (\[18F\]FluorThanatrace) in patients and calculate human dosimetry. * Evaluate change in \[18F\]FluorThanatrace uptake measures after therapy

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for Dynamic cohort * Participants will be ≥ 18 years of age * 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) * At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT) Exclusion Criteria for Dynamic cohort * 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 at screening. * 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

Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts