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Trial record 5 of 13 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | brain cancer | United States | Start date from 01/06/2021 to 04/08/2021

18F-FMAU PET/CT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases

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ClinicalTrials.gov Identifier: NCT04752267
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Anatomic Stage IV Breast Cancer AJCC v8 Clinical Stage IV Cutaneous Melanoma AJCC v8 Glioma Malignant Brain Neoplasm Metastatic Breast Carcinoma Metastatic Colon Carcinoma Metastatic Kidney Carcinoma Metastatic Lung Carcinoma Metastatic Malignant Neoplasm in the Brain Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 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 Procedure: Computed Tomography Drug: 18F-FMAU Procedure: Multiparametric Magnetic Resonance Imaging Procedure: Positron Emission Tomography Early Phase 1

Detailed 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.

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Study Type : Interventional
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 15, 2023


Arm Intervention/treatment
Experimental: Diagnostic (18F-FMAU, PET/CT, mpMRI)
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.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: 18F-FMAU
Given IV
Other Name: Fluorine F 18 d-FMAU

Procedure: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
  • Multiparametric MRI

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Correlation between multiparametric magnetic resonance imaging (mpMRI) radiomics and dynamic fluorine F 18 (18F)-FAMU (FMAU) positron emission tomography (PET) kinetic analysis parameters [ Time Frame: Up to 1 year ]
    Scatter plots will be used to illustrate the pattern of correlation. For normality distributed data, Pearson correlation will be used; otherwise, Spearman correlation will be used. There will be 90 pairs of correlations. To further confirm the robustness of the correlation finding, the Benjamini-Hochberg procedure will be applied to prevent false discovery.

  2. Different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters [ Time Frame: Up to 1 year ]
    Interesting patterns will be observed at individual subject level for the difference between presence or absence of recurrent tumor, which defined as either underlying immunohistochemistry (Ki67-MIB proliferation marker, when tissue sample is available, or a binary proxy marker of subsequent clinical management decision (with wait-and-watch strategy for 1 month after imaging studies considered as "absence" of recurrent tumor, otherwise marked as "presence" of recurrent tumor). Heatmap will be used with subject identification as x-axis and each radiomic/kinetic feature as y-axis. Features will be divided by categories to facilitate the visualization of patterns.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years, both men and women
  • Documented history of either primary brain tumor (e.g. glioma) or metastatic brain tumor from another primary cancer (e.g. lung, breast, colon, melanoma, kidney)
  • Documented radiation therapy regardless of treatments prior to radiation therapy

Exclusion Criteria:

  • Unable to give consent
  • Inability to remain motionless during imaging studies
  • Intractable seizures
  • Claustrophobia
  • Implantable devices incompatible with magnetic resonance (MR) environment

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 ClinicalTrials.gov identifier (NCT number): NCT04752267


Contacts
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Contact: Sanjna Mani 323-442-7469 Sanjna.Mani@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Sanjna Mani       Sanjna.Mani@med.usc.edu   
Principal Investigator: Hossein Jadvar, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Hossein Jadvar, MD University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT04752267    
Other Study ID Numbers: 6B-20-1
NCI-2021-00706 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6B-20-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Neoplasms
Colonic Neoplasms
Brain Neoplasms
Skin Neoplasms
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Urologic Neoplasms
Urogenital Neoplasms
Carcinoma
Melanoma
Carcinoma, Renal Cell
Breast Diseases
Skin Diseases