Fluorine F 18 Fluorthanatrace PET/CT in Treating Participants With Primary or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | December 18, 2018 |
| End Date: | August 31, 2020 |
| Contact: | Lilie Lin |
| Email: | lllin@mdanderson.org |
| Phone: | 713-563-2300 |
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
This trial studies how well fluorine F 18 fluorthanatrace positron emission tomography
(PET)/computed tomography (CT) works in treating participants ovarian, fallopian tube, or
primary peritoneal cancer that is primary or has come back. 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 participants with ovarian, fallopian tube, or primary
peritoneal cancer.
(PET)/computed tomography (CT) works in treating participants ovarian, fallopian tube, or
primary peritoneal cancer that is primary or has come back. 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 participants with ovarian, fallopian tube, or primary
peritoneal cancer.
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:
Participants 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, participants receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18
fluorthanatrace ([18F]FTT) PET/CT over 1 hour.
After completion of study treatment, participants are followed up at 24 hours.
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:
Participants 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, participants receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18
fluorthanatrace ([18F]FTT) PET/CT over 1 hour.
After completion of study treatment, participants are followed up at 24 hours.
Inclusion Criteria:
- 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) for women only.
- 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 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.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Lilie L. Lin
Phone: 713-563-2300
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