Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma

NCT02176720 | Terminated Phase 1 FDA Drug

• 3 other identifiers: Pro000098571216381013-0158
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Glioblastoma; Glioblastoma Multiforme

Keywords

Glioma; Glioblastoma; Glioblastoma multiforme; GBM; Recurrence; PET; FDOPA

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy compared to standard diagnostics without PET

  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".

  5 years

Secondary Outcomes (1)

• Impact of FDOPA PET on patient management

  [ Time Frame: 7 years ]

Study Arms (2)

Standard diagnostics without PET

NO INTERVENTION

Standard of care brain imaging modalities, predominantly MRI

FDOPA PET-CT

EXPERIMENTAL

PET-CT with administration of FDOPA as an experimental radiopharmaceutical. This arm includes standard of care imaging plus FDOPA PET-CT

Drug: FDOPA PET

Interventions

FDOPA PET DRUG

\[18F\]FDOPA radiopharmaceutical will be intravenousely injected for PET-CT scanning of the brain.

Also known as: 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

FDOPA PET-CT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Houston Methodist Research Institute PET Center

Houston, Texas, 77030, United States

Location

Related Links

• Collaborator

MeSH Terms

Conditions

Glioma; Glioblastoma; Recurrence

Interventions

fluorodopa F 18

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Lee, MD, PhD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 27, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)