68Ga-citrate PET/MR Imaging for Glioma

NCT ID: NCT03335280

Last Updated: 2020-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-04-24

Brief Summary

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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.

Detailed Description

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive for PTEN deletion

Confirmed by immunohistochemistry of tissue biopsy

68Ga-citrate PET/MR

Intervention Type 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

Confirmed by immunohistochemistry of tissue biopsy

68Ga-citrate PET/MR

Intervention Type 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.

Interventions

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68Ga-citrate PET/MR

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Brain Tumor Association

OTHER

Sponsor Role collaborator

Susan Chang

OTHER

Sponsor Role lead

Responsible Party

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Susan Chang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Susan Chang, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2020-00335

Identifier Type: REGISTRY

Identifier Source: secondary_id

181016

Identifier Type: -

Identifier Source: org_study_id

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