PET Imaging of Ovarian Carcinoma With 18F-FSPG

NCT02872519 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: VICC GYN 15142
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.

  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

  Up to 2 years

Study Arms (1)

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); Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

Interventions

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

Given by IV

Experimental

Positron Emission Tomography PROCEDURE

Undergo scan

Experimental

Laboratory Biomarker Analysis OTHER

Laboratory Biomarker Analysis

Experimental

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

4-(3-fluoropropyl)glutamic acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marta Crispens, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 19, 2016
• Study Start: June 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: June 6, 2018

Record last verified: 2018-06