18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02037945
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : February 2, 2018
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The main purpose of this study is to determine the distribution of 18F Fluorocholine (18F-FCH) in the brain which can help distinguishing radiation-induced scarring from tumor regrowth. In addition, the study will measure levels of 18F-FCH in the blood and (if applicable) in the brain lesion tissue that is removed as part of the planned brain surgery.

Condition or disease Intervention/treatment Phase
Brain Metastases Procedure: 18F-FCH PET Scan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-Fluorocholine (18F-FCho) to Distinguish Necrosis From Recurrence in Brain Metastases
Actual Study Start Date : January 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: pts with brain mets going for surgery
This study will enroll patients with brain metastases that are evolving after SRS who are scheduled to undergo surgical resection. Eligible patients will undergo an 18F-FCH PET study 1-to-7 days pre-operatively. Although no toxicity has been previously reported following 18F-FCH administration, patients will be contacted 1-3 days after their scan and asked whether they experienced any adverse effects. The patients who have a positive 18F-FCH PET study (in which there is visible focal "hot spots" (a focus of lesion/normal white matter ratio >1.4) of 18F-FCH) will undergo further evaluation and be administered a second administration oflower activity 18F-FCH at the time of surgery. The purpose of the second 18F-FCH administration in the operating room is to further elucidate the tissue distribution of 18F-FCH radioactivity with respect to the histopathology of the surgically resected tissue.
Procedure: 18F-FCH PET Scan

Primary Outcome Measures :
  1. to distinguish radiation necrosis from progressive tumor [ Time Frame: 1 year ]
    by comparing the PET imaging results to the surgical pathology

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient and/or guardian is able to provide written informed consent prior to study registration
  • Age ≥ 21 years old
  • Evolving brain lesions post SRS requiring neurosurgical resection (whether for symptomatic control or to establish pathology)

Exclusion Criteria:

  • Inability to undergo a MRI or PET scan (e.g., claustrophobia or metal implant)
  • Pregnant or nursing female
  • Unable to cooperate for PET/CT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02037945

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Kathryn Beal, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT02037945     History of Changes
Other Study ID Numbers: 13-199
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
18F-Fluorocholine (18F-FCho)
Pet Scan

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Disease Attributes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases