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

Inclusion Criteria for Biodistribution 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 metastatic 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)

- Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures.

Exclusion Criteria for Biodistribution 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

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)

- Clinical plan for biopsy or surgical procedure of at least one site of known or
suspected cancer

- Willing to consent to collection of pathology tissue for the purposes of research at
the time of clinical biopsy or surgical procedure.

- Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures.

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.

- No clinical plan for biopsy or surgical procedure of known or suspected cancer

- 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