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

Abramson Cancer Center at Penn Medicine

Status and phase: Enrolling; Phase 1

Conditions: Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Treatments: Radiation: PET/CT imaging sessions; Drug: [18F]FluorThanatrace

Study type: Interventional

Funder types: Other

Identifiers

NCT02637934

UPCC 18815

Details and patient eligibility

About

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.

Full description

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

Enrollment: 35 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

Biodistribution

Experimental group

Description:

The Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution \[18F\]FTT PET/CT scans over a period of approximately 4 hours. Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects.

Treatment:

Drug: [18F]FluorThanatrace

Radiation: PET/CT imaging sessions

Dynamic

Experimental group

Description:

The Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of \[18F\]FTT.

Treatment:

Drug: [18F]FluorThanatrace

Radiation: PET/CT imaging sessions