Brief Title
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF
Official Title
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
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.
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. Evaluate the safety of [18F]Fluorthanatrace. II. Correlate [18F]Fluorthanatrace uptake
measures with BRCA mutation status. III. Correlate [18F]Fluorthanatrace uptake measures with
poly [ADP-ribose] polymerase (PARP-1) activity in tumor tissue samples in patients who
undergo biopsies.
IV. 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
Secondary Outcome
Incidence of adverse events
Condition
Breast Carcinoma
Intervention
Computed Tomography
Study Arms / Comparison Groups
Treatment (FDG PET/CT, [18F]FTT PET/CT)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
120
Start Date
December 18, 2018
Completion Date
December 31, 2023
Primary Completion Date
December 31, 2022
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lilie L Lin, 713-563-2300, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03604315
Organization ID
2017-0319
Secondary IDs
NCI-2018-01137
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Lilie L Lin, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
November 2019