Clinical trial NCT03604315: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Carcinoma
Fallopian Tube Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

- 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:

* Evaluate the safety of \[18F\]Fluorthanatrace.
* Correlate \[18F\]Fluorthanatrace uptake measures with BRCA mutation status.
* Correlate \[18F\]Fluorthanatrace uptake measures with poly \[ADP-ribose\] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies.
* Evaluate change in \[18F\]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation.
* To confirm the variability of imaging findings from repeated \[18F\]FTT PET/CT over 1 week before treatment initiation
* Determine the change in \[18F\]FluorThanatrace uptake before treatment initiation and at time of clinical progression
* Correlate \[18F\]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status

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.

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.

Primary outcomes:
measure: Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography
timeFrame: Up to 4 years
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 4 years
measure: BRCA mutation status
timeFrame: Up to 4 years
measure: PARP-1 activity in tumor tissue samples
timeFrame: Up to 4 years
measure: Change in fluorine F 18 fluorthanatrace uptake measures after therapy
timeFrame: Baseline up to 4 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lilie L Lin
role: PRINCIPAL_INVESTIGATOR
References: