Brief Title
PET Imaging of Ovarian Carcinoma With 18F-FSPG
Official Title
PET Imaging of Ovarian Carcinoma With 18F-FSPG
Brief Summary
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG
[(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients
with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as
18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has
spread.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
Secondary Outcome
Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
Condition
Stage IIIA Fallopian Tube Cancer
Intervention
(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)
Study Arms / Comparison Groups
Experimental
Description: Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B).
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
Drug
Estimated Enrollment
0
Start Date
June 2018
Completion Date
August 2020
Primary Completion Date
August 2019
Eligibility Criteria
Inclusion Criteria:
- Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or
peritoneal.
- Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.
- Adequate performance status, ECOG 0, 1, 2.
- Adequate organ function:
- PCV > 30 (with or without transfusion)
- WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI
considers levels of 3,000- 4,000 as mild suppression for drug trials,
specifically not requiring treatment.
- Platelet count > 150, 000 and < 1,000,000
- Cr < 1.5
- LFTS < 1.5 x ULN
- Have undergone or have agreed to undergo standard of care CT of the chest, abdomen,
and pelvis. 18F-FSPG PET imaging will be performed as investigational studies.
- No prior treatment for ovarian cancer
- have undergone or agree to undergo standard of care imaging for ovarian cancer with CT
chest, abdomen, and pelvis.
Exclusion Criteria:
- Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
- Pregnant and breastfeeding
- Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
- Other poorly controlled medical conditions that in the opinion of the surgeon, make
them not a candidate for primary cytoreductive surgery.
- CT of chest, abdomen, pelvis demonstrates:
- Any disease in the thoracic cavity > 1 cm.
- Any suprarenal lymphadenopathy > 1 cm.
- Liver metastases > 1 cm.
- Disease in the porta hepatis or gallbladder fossa > 1 cm.
- Pleural effusion > 50% volume of the chest cavity on chest x-ray.
- Omental extension to the stomach, spleen, or lesser sac.
- Extension to the pelvic sidewall (this criteria may also be assessed on
physical examination.
- involvement of the root of the mesentery.
- Decline procedures that might be necessary for optimal primary cytoreduction (i.e.
colostomy or splenectomy).
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Marta Crispens, MD, ,
Administrative Informations
NCT ID
NCT02872519
Organization ID
VICC GYN 15142
Responsible Party
Principal Investigator
Study Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Marta Crispens, MD, Principal Investigator, Vanderbilt University Medical Center
Verification Date
June 2018