68Ga-PSMA PET in Diagnosing Metastasis in Patients With Ovarian Cancer

Ovarian Carcinoma Clinical Trial

Official title:

Gallium-68 Prostate Specific Membrane Antigen for Ovarian Cancer: A Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857087
• Other study ID #: 174017
• Secondary ID: NCI-2018-02331
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA) positron emission tomography (PET) works in patients with ovarian cancer to detect whether the tumor has spread to other places in the body. 68Ga-PSMA is a radioactive substance that binds to blood vessels around the ovarian cancer and can be imaged using PET. Diagnostic procedures, such as PET, may help find and diagnose find out how far the disease has spread.

Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility and utility of 68Ga-PSMA PET imaging patients with ovarian cancer.

II. Determine detection sensitivity for nodal metastases for PSMA PET stratified by node size.

SECONDARY OBJECTIVES:

I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET and PSMA expression in surgical resection specimens.

EXPLORATORY OBJECTIVES:

I. To explore heterogeneity of 68Ga-PSMA PET uptake in cases of metastatic ovarian cancer.

II. To determine the relationship between 68Ga-PSMA PET uptake, diffusion weighted imaging, and MRI-derived tumor perfusion.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. After about 60 minutes, patients undergo PET/magnetic resonance imaging (MRI) for approximately over 50-60 minutes. Patients may undergo an optional repeat gallium Ga 68-labeled PSMA-11 PET between 8 and 12 weeks after completion of the first PET/MRI.

After completion of study, patients are followed up at 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with one of the following, identified on prior imaging (CT, MRI or Ultrasound):

1. adnexal mass

2. abdominal or pelvic tumor suspicious for ovarian cancer metastases (either suspected on clinical grounds, or known from prior tissue sampling)

2. Female,

3. Age >= 18 years

4. Creatinine </= 1.5 mg/dL

5. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Patient unlikely to comply with study procedure, restrictions and requirements and judged by the investigator to be unsuitable for study participation.

Related Conditions & MeSH terms

• Ovarian Carcinoma

Intervention

Drug:
• Gallium Ga 68-labeled PSMA-11
Given IV

Procedure:
• Magnetic Resonance Imaging (MRI)
Given PET/MRI
• Positron Emission Tomography (PET)
Undergo PET/MRI

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of gallium Ga 68-labeled PSMA-11 positron emission tomography (PET) positive lesions detected by standard staging scans	Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging computed tomography/magnetic resonance imaging (CT/MRI). In addition, the mean, range, and standard deviation of standardized uptake value maximum (SUVmax) (across all visualized lesions per patient) and SUVmax-average (ave) (across all patients in the study cohort) will be descriptively reported.	Study Visit Day 1
Primary	Number of overall ovarian cancer lesions detected by standard staging scans	Will be descriptively reported for each patient and correlated with the lesions observed in standard imaging CT/MRI.	Study Visit Day 1
Primary	Average maximum standard uptake value (SUVmax)	The mean, range, and standard deviation of SUVmax across all visualized lesions per patient will be descriptively reported.	Study Visit Day 1
Primary	Number of lymph nodes detected by PET	Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.	Study Visit Day 1
Primary	Number of lymph nodes detected by MRI	Will be compared and stratified by lymph node size. For patients undergoing surgical resection, this will be compared with the number of involved lymph nodes by surgical resection. For lymph nodes that are not resected, the behavior on follow-up clinical CT scans (if available) will be used to assess for involvement.	Study Visit Day 1
Secondary	Correlation between targeted molecular uptake of 68Ga-PSMA PET and prostate-specific membrane antigen (PSMA) expression in surgical resection specimens	For patients undergoing surgical resection, the 68Ga PSMA-PET uptake will be correlated with PSMA expression in the primary tumor as well as metastatic sites. PSMA expression measurement is available as a core service from the cancer center	Study Visit Day 1