PET Imaging of Ovarian Carcinoma With 18F-FSPG

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 Overview

• Status: Withdrawn
• 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
• Intervention / Treatment: Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG); Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

• Study Type: Interventional
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG); Given by IV; Procedure: Positron Emission Tomography; Undergo scan; Other: Laboratory Biomarker Analysis; Laboratory Biomarker Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values	Up to 2 years
Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET	Up to 2 years
Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.	All imaging data (SUV) will be correlated to definitive, ex vivo diagnostic pathology and immunoreactivity (xC-, CD44), which will be carried out for every patient with resected tissue. and, when IHC scoring will be in terms of strength of immunostaining (scored on an ordinal scale of 0 3). This treatment of lesion-based sensitivity and specificity has not been previously described in the ovarian cancer literature.	Up to 2 years
Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation		Up to 2 years
Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria		Up to 2 years
Conditional predictive models of imaging performance and agreement	We will test that lesion 18F-FSPG PET SUV's are significantly greater than background (normal liver tissue) by tissue assessment of number of lesions noted in each arm and after treatment.	Up to 2 years

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Marta Crispens, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (ESTIMATE): August 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Abdominal Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: VICC GYN 15142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No