PET Imaging of Ovarian Carcinoma With 18F-FSPG

Early Phase 1

Withdrawn

• Conditions: Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IV Ovarian Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Primary Peritoneal Cancer
• Interventions: Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG); Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02872519
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Status Verified: 2018-06
• Study Start: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06
• Primary Completion: 2019-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Positron Emission Tomography	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).
Experimental	(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)	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).
Experimental	Laboratory Biomarker Analysis	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).

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation	Up to 2 years