PET Imaging of Ovarian Carcinoma With 18F-FSPG

• Status: Withdrawn
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)

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).