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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02037945
First received: January 14, 2014
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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 Intervention
Brain Metastases Procedure: 18F-FCH PET Scan

Study Type: Interventional
Study Design: 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

Further study details as provided by Memorial Sloan Kettering Cancer Center:

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


Enrollment: 19
Actual Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037945

Locations
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)
Investigators
Principal Investigator: Kathryn Beal, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02037945     History of Changes
Other Study ID Numbers: 13-199
Study First Received: January 14, 2014
Last Updated: April 4, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
18F-Fluorocholine (18F-FCho)
Pet Scan
MRI
13-199

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

ClinicalTrials.gov processed this record on August 23, 2017