We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02176720
Recruitment Status : Terminated (PI left HMRI)
First Posted : June 27, 2014
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
The Methodist Hospital Research Institute

Brief Summary:
It was previously shown that [18F]Fluorodopa (FDOPA) PET imaging results in intended management changes in 41% of brain tumor patients. However, its impact on patient outcome defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory agencies require randomized trials to determine the impact of PET on patient management and outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.

Condition or disease Intervention/treatment Phase
Glioma Glioblastoma Glioblastoma Multiforme Drug: FDOPA PET Phase 1

Detailed Description:

Malignant gliomas are aggressive primary brain tumors that almost always lead to rapid patient deterioration and death. Timely diagnosis of recurrent disease as well as accurate monitoring of therapeutic responses is critically important in glioblastoma patients.

Despite introduction of new treatment approaches patient prognosis is poor with less than half of the patients being progression-free during the first 6 months after diagnosis of disease recurrence (6-month-progression-free survival rates of 46%).

The current diagnostic standard of care for diagnosing and monitoring brain tumors is contrast-enhanced, multi-planar magnetic resonance imaging (MRI). However, the ability of MRI for early detection of disease recurrence or progression is limited. Moreover, determination of treatment responses is difficult since benign tissue changes after radiation and/or chemotherapy can have the appearance of tumor recurrence or progression on MRI. Positron emission tomography (PET) is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of substances (tracers) that are injected via a hand or arm vein. These substances can track certain features of cancers that can be visualized by using the PET-CT scanner. For instance, a number of different PET-tracers have been used to study brain tumor metabolism and to detect primary or recurrent tumors. These include tracers of glucose ([18F]FDG) and amino acid metabolism (e.g., [11C] methionine and [18F]FDOPA). Metabolic imaging of brain tumors with amino acid analogues has advantages over FDG. Since FDG assess glucose metabolism and the normal brain consumes a lot of glucose it can be difficult to detect tumors against high glucose use of normal brain tissue. FDOPA has been successfully used clinically for many years. The advantage of FDOPA is that normal brain tissue consumes very little FDOPA. Thus, tumors can be seen easily against a low background activity.

FDOPA PET imaging detects brain tumors with a very high accuracy and affects the management of 40% of patients. However, its impact on patient outcome defined as survival, costs, and/or quality of life has not been demonstrated.

Randomized trials are needed to evaluate the impact of PET on patient management and outcome. We will determine this by randomizing patients with suspected recurrence of glioblastoma into those who are managed using conventional diagnostic imaging versus those who will receive conventional imaging plus FDOPA PET. Randomization is like flipping a coin. Patients will have a 50% chance to undergo standard imaging or standard imaging combined with FDOPA PET.

Approximately 25-40% of the patients with suspected tumor recurrence will have pseudo-progression on MRI (i.e., the images suggest that there is tumor recurrence when there is in fact no recurrence). These patients will have correctly negative FDOPA PET scans. In these patient initiation of treatment can be postponed. In contrast, patients with positive FDOPA PET scans will undergo some kind of treatment at the discretion of the treating physician (radiation therapy, chemotherapy or surgery). We will find out whether the management and treatment change that is based on FDOPA PET affects the survival of patients and affects the costs of caring for the patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Metabolic Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma FDOPA PET-CT
Study Start Date : May 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard diagnostics without PET
Standard of care brain imaging modalities, predominantly MRI
Experimental: FDOPA PET-CT
PET-CT with administration of FDOPA as an experimental radiopharmaceutical. This arm includes standard of care imaging plus FDOPA PET-CT
Drug: FDOPA PET
[18F]FDOPA radiopharmaceutical will be intravenousely injected for PET-CT scanning of the brain.
Other Names:
  • FDOPA PET-CT
  • Fluorine-18-L-dihydroxyphenylalanine
  • Fluorine-18-L-dihydroxyphenylalanine PET
  • Fluorine-18-L-dihydroxyphenylalanine PET-CT
  • [18F]FDOPA
  • [18F]FDOPA PET
  • [18F]FDOPA PET-CT




Primary Outcome Measures :
  1. Diagnostic accuracy compared to standard diagnostics without PET [ Time Frame: 5 years ]
    Imaging findings will be validated by histopathology, clinical follow-up and/or repetitive imaging. If no histopathology within 3 months is available, clinical follow-up and imaging findings will be used for validation. If within 6 months of randomization no clinical progression nor progression on other imaging modalities is found, the patient will be rated as "no disease present at time of imaging".


Secondary Outcome Measures :
  1. Impact of FDOPA PET on patient management [ Time Frame: [ Time Frame: 7 years ] ]
    Overall and progression free survival will be assessed according to the standard of clinical care with a minimum follow-up time of two years after randomization. In this study protocol there are no pre-set follow-up algorithms, however in clinical routine a follow-up every three months is standard.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Suspected first recurrence of a glioblastoma tumor by clinical measures and/or MRI
  • Age 18 and older

Exclusion Criteria:

  • Breast feeding/ Pregnancy
  • Severe psychiatric illness
  • Primary diagnosis of a glioblastoma

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): NCT02176720


Locations
Layout table for location information
United States, Texas
Houston Methodist Research Institute PET Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital Research Institute
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Daniel Lee, MD, PhD The Methodist Hospital Research Institute
Additional Information:
Layout table for additonal information
Responsible Party: The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02176720    
Other Study ID Numbers: Pro00009857
121638 ( Other Identifier: Principal Investigator )
1013-0158 ( Other Identifier: HMRI IRB )
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Methodist Hospital Research Institute:
Glioma
Glioblastoma
Glioblastoma multiforme
GBM
Recurrence
PET
FDOPA
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Glioma
Recurrence
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes
Fluorides
Dihydroxyphenylalanine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action