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Clinical Trial Summary

This early phase I trial tests the use of a radioactive tracer (a drug that is visible during an imaging test) known as 18F-FMAU, for imaging with positron emission tomography/computed tomography (PET/CT) in patients with brain cancer or cancer that has spread to the brain (brain metastases). A PET/CT scan is an imaging test that uses a small amount of radioactive tracer (given through the vein) to take detailed pictures of areas inside the body where the tracer is taken up. 18F-FMAU may also help find the cancer and how far the disease has spread. Magnetic resonance imaging (MRI) is a type of imaging test used to diagnose brain tumors. 18F-FMAU PET/CT in addition to MRI may make the finding and diagnosing of brain tumor easier.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Assess the correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic 2'-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (FMAU) PET kinetic analysis parameters. II. Explore the different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters between patients with presence or absence of recurrent tumor. OUTLINE: Patients receive 18F-FMAU intravenously (IV) and undergo a PET/CT scan over 60 minutes. Patients then undergo standard of care mpMRI over approximately 45 minutes. After completion of study intervention, patients are followed up at 24-96 hours after their 18F-FMAU PET/CT scan. ;


Study Design


Related Conditions & MeSH terms

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Brain Neoplasms
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Renal Cell
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Colonic Neoplasms
  • Glioma
  • Kidney Neoplasms
  • Lung Neoplasms
  • Malignant Brain Neoplasm
  • Melanoma
  • Metastatic Breast Carcinoma
  • Metastatic Colon Carcinoma
  • Metastatic Kidney Carcinoma
  • Metastatic Lung Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Melanoma
  • Neoplasms
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Skin Neoplasms
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Stage IVA Colon Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Colon Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Stage IVC Colon Cancer AJCC v8

NCT number NCT04752267
Study type Interventional
Source University of Southern California
Contact
Status Completed
Phase Early Phase 1
Start date February 15, 2021
Completion date September 18, 2023

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