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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Brain Metastases

Treatments

Procedure: 18F-FCH PET Scan

Study type

Interventional

Funder types

Other
NIH

Identifiers

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

19 participants in 1 patient group

pts with brain mets going for surgery
Experimental group
Description:
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.
Treatment:
Procedure: 18F-FCH PET Scan

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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