Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) vs. Adv. Magnetic Resonance (MR) Techniques in Recurrent Glioma

NCT02241668 | Withdrawn

• 1 other identifier: 2013-0283
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to learn if using a new imaging solution, 3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help doctors determine if your brain lesion is from the tumor returning or the effects of previous treatments. The results of this imaging scan (called an FLT PET scan) will be compared to the results of a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have outside of this study.

Conditions

Brain Tumor

Keywords

Brain tumor; 3'-Deoxy-3'-18f-Fluorothymidine; Fluoro-L-Thymidine Positron Emission Tomography; FLT PET; Magnetic resonance imaging; MRI

Outcome Measures

Primary Outcomes (1)

• Performance of Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) and Perfusion Magnetic Resonance Imaging (MRI) in the Diagnosis of Recurrent High-Grade Glial Tumor

  Performance (sensitivity, specificity, negative/ positive predictive values) for MR perfusion and FLT PET made using prior reported values (PEI \> 20% 10 and normalized uptake \>1.3 17, respectively). Particular attention placed on the location for ROI's and pathology sampling in large heterogenous lesions. Additional, exploratory analysis performed to determine post-hoc optimal cut-off values for classifying glioma vs. necrosis. Logistic regression used to fit a model using a combination of a perfusion values, spectroscopy values, diffusion values, and values from FLT PET.

  1 day

Study Arms (1)

FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine

EXPERIMENTAL

After a magnetic resonance imaging (MRI) scan of brain performed, an FLT PET scan using 3'-Deoxy-3'-18f-Fluorothymidine solution performed. After solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. The entire procedure should last about 60-70 minutes.

Procedure: PET Scan; Drug: 3'-Deoxy-3'-18f-Fluorothymidine

Interventions

PET Scan PROCEDURE

FLT Pet Scan performed about 60 minutes after 3'-Deoxy-3'-18f-Fluorothymidine solution injected.

Also known as: Positron Emission Tomography

FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine

3'-Deoxy-3'-18f-Fluorothymidine DRUG

3'-Deoxy-3'-18f-Fluorothymidine solution injected through a central venous catheter after MRI scan. After solution injected into a vein, PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. Entire procedure should last about 60-70 minutes.

FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \>/= 18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
• Patient is a candidate for cerebral tumor resection due to an enhancing brain lesion, with history of previous pathologically proven primary brain tumor (WHO grade II-IV diffuse glioma)
• Patient had diffuse glioma (WHO grade 2 - 4) and as part of their treatment received radiation therapy and Temozolomide (a first-line chemotherapeutic agent).
• Patient will have subsequently developed an enhancing brain mass greater than 1cm in diameter, at least 6 months after finishing radiation therapy (to differentiate from the more acute treatment related effect of "pseudo-progression").
• As the predominate means of determining TRN versus recurrent glial tumor at MD Anderson, a brain tumor/ necrosis protocol is ordered as clinically indicated.
• Patient's clinician based on the clinical and MR information wants to proceed with biopsy or surgical resection within 30 days from when the brain tumor MR protocol was performed. The patient meets with the neurosurgeon and agrees to surgical biopsy or resection.
• Patient is able to understand and give consent to participation in the study
• Patient has received as part of their care the Brain Tumor Imaging protocol.
• Patient agrees to undergo, prior to the procedure, FLT PET at CABI

You may not qualify if:

• The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy/ resection could not be safely performed
• Claustrophobia that does not readily respond to oral medication
• Allergy to Fluoro-L-Thymidine
• Pregnant or lactating (Based on self-reported and clinical care testing with physicians before study participation)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GE Healthcare: collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy; alovudine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eric Rohren, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 16, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2016-02