PET Imaging of Ovarian Carcinoma With 18F-FSPG

NCT ID: NCT02872519

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2020-08-31

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.

Conditions

Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental

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).

Group Type: EXPERIMENTAL

(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)

Intervention Type: DRUG

Given by IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo scan

Laboratory Biomarker Analysis

Intervention Type: OTHER

Laboratory Biomarker Analysis

Interventions

(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)

Given by IV

Intervention Type: DRUG

Positron Emission Tomography

Undergo scan

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Laboratory Biomarker Analysis

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Marta Crispens, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Crispens, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Other Identifiers

VICC GYN 15142

Identifier Type: -

Identifier Source: org_study_id