TheranosticTrials.org

Clinical Trial · NCT02872519

PET Imaging of Ovarian Carcinoma With 18F-FSPG

Overview

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.

Sponsor

Vanderbilt-Ingram Cancer Center

Phase

Early Phase 1

Contacts

Marta Crispens, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02872519

Drug / Compound

FSPG

Isotope(s):
Target(s):
  • Cystine/glutamate antiporter
Ligand Class: Small Molecules
Linker: 3-fluoropropyl

Eligibility

Inclusion

  • Adequate performance status, ECOG 0, 1, 2.
  • Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.
  • No prior treatment for ovarian cancer
  • PCV \> 30 (with or without transfusion)
  • 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.
  • Adequate organ function:
  • 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.
  • have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.
  • Platelet count \> 150, 000 and \< 1,000,000
  • Cr \< 1.5
  • LFTS \< 1.5 x ULN
  • Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.

Exclusion

  • involvement of the root of the mesentery.
  • Pregnant and breastfeeding
  • Extension to the pelvic sidewall (this criteria may also be assessed on physical examination.
  • Pleural effusion \> 50% volume of the chest cavity on chest x-ray.
  • Poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
  • Omental extension to the stomach, spleen, or lesser sac.
  • Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.
  • Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).
  • Any disease in the thoracic cavity \> 1 cm.
  • Disease in the porta hepatis or gallbladder fossa \> 1 cm.
  • Any suprarenal lymphadenopathy \> 1 cm.
  • Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
  • CT of chest, abdomen, pelvis demonstrates:
  • Liver metastases \> 1 cm.