PET Imaging of Ovarian Carcinoma With 18F-FSPG

Vanderbilt University Medical Center

Status and phase: Withdrawn; Early Phase 1

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

Treatments: Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG); Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02872519

VICC GYN 15142

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Experimental

Experimental group

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).

Treatment:

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

Other: Laboratory Biomarker Analysis

Procedure: Positron Emission Tomography