Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma

NCT01813877 | Completed

• 3 other identifiers: 12-000939NCI-2013-01421FDOPA12-000939
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

It was previously shown that 18F-DOPA 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 18F-DOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.

Conditions

Glioma; Glioblastoma

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

  7 years

Study Arms (2)

Standard Diagnostics without PET

NO INTERVENTION

Diagnostics with PET

EXPERIMENTAL

All 18F-DOPA PET/CT studies will be interpreted qualitatively during a clinical readout session. Based on a previous study scans will be classified as positive if tumor regions defined on CT exhibited tracer uptake above the level of the contra-lateral caudate nucleus. Scans will be classified as negative if tumor 18F-FDOPA uptake is lower than that of the contra lateral caudate nucleus. Uptake at the level of the contra-lateral caudate will be considered equivocal for malignancy.

Radiation: FDOPA PET/CT

Interventions

FDOPA PET/CT RADIATION

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, in this instance the amino acid 18F-DOPA.

Diagnostics with PET

Eligibility Criteria

• Age: 18 Years - 99 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 18-99 years

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Kaiser Permanente: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Links

• Ahmanson Imaging Division

MeSH Terms

Conditions

Glioma; Glioblastoma

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

Study Officials

• Johannes Czernin, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 19, 2013
• Study Start: August 22, 2012
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-05

Locations

US (1)