68Ga-citrate PET/MR Imaging for Glioma

NCT03335280 | Terminated FDA Drug

• 2 other identifiers: 181016NCI-2020-00335
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Maximum standardized uptake value (SUVmax)

  The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion.

  1 day

Study Arms (2)

Positive for PTEN deletion

Confirmed by immunohistochemistry of tissue biopsy

Drug: 68Ga-citrate PET/MR

Negative for PTEN deletion

Confirmed by immunohistochemistry of tissue biopsy

Drug: 68Ga-citrate PET/MR

Interventions

68Ga-citrate PET/MR DRUG

Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes.

Negative for PTEN deletion; Positive for PTEN deletion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with WHO grade 3 or 4 glioma planning to undergo surgery with availability of immunohistochemistry of tissue

You may qualify if:

• World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery
• Age \>= 18 yrs.
• Karnofsky performance status of \>= 60
• Ability to understand a written informed consent document, and the willingness to sign it.
• Cohort A:
• \- Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy
• Cohort B:
• \- Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy

You may not qualify if:

• Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman)
• Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)

Sponsors & Collaborators

• Susan Chang: lead
• American Brain Tumor Association: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Susan Chang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: November 7, 2017
• Study Start: February 26, 2019
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)