Recruiting
Phase 1

[^18F] FTT

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03604315

Conditions

Breast Carcinoma

Fallopian Tube Carcinoma

Ovarian Carcinoma

Primary Peritoneal Carcinoma

Recurrent Fallopian Tube Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Computed Tomography

Fludeoxyglucose F-18

Fluorine F 18 Fluorthanatrace

Positron Emission Tomography

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Fallopian Tube Carcinoma

Ovarian Carcinoma

Primary Peritoneal Carcinoma

Recurrent Fallopian Tube Carcinoma

Study ID

NCT03604315

Start date

Dec 18, 2018

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (FDG PET/CT, [18F]FTT PET/CT)

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.

Interventions

Computed Tomography

Undergo FDG PET/CT

Computed Tomography

Undergo \[18F\]FTT PET/CT

Fludeoxyglucose F-18

Given IV

Fluorine F 18 Fluorthanatrace

Given IV

Positron Emission Tomography

Undergo FDG PET/CT

Positron Emission Tomography

Undergo \[18F\]FTT PET/CT

Primary outcome measure

  • Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Lilie Lin

713-563-2300lllin@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lilie L. Lin, MD

713-563-2300lllin@mdanderson.org

Principal Investigator:

Lilie L. Lin, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-19.