PET Imaging of Ovarian Carcinoma With 18F-FSPG

Stage IV Ovarian Cancer Clinical Trial

Official title:

PET Imaging of Ovarian Carcinoma With 18F-FSPG

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02872519
• Other study ID #: VICC GYN 15142
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2018
• Est. completion date: August 2020

Study information

• Verified date: June 2018
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Peritoneal Neoplasms
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values		Up to 2 years
Primary	Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET		Up to 2 years
Primary	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	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
Secondary	Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation		Up to 2 years
Secondary	Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria		Up to 2 years
Secondary	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