Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET)

NCT02022800 | Completed DMC

• 1 other identifier: 2012/56
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at least 3 months in order to clarify the situation, with a potential delay in diagnosis and therefore therapeutic care. The contribution of cerebral molecular imagery could allow for new additional information to be brought in or to increase the confidence index in the diagnosis in order to comfort the therapeutic collective attitude proposed in the multidisciplinary meeting (MM). 3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid, Position Emission Tomography (PET), allows for the studying in vivo of the proteic transmembrane transport in gliomatous tissue; active transport happens through a sodic-independent canal, increased in malicious transformations, and in which kinetics can give an indication regarding the development of the primary tumor. In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is independent of the state of integrity of the BBB and whose only function is metabolic tissue activity. This method of imagery thus appears as a promising contribution to conventional imagery. Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose), similar to the largely used glucose in oncologic molecular imagery, exploration of harmful glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a level of reference. The best performances in terms of positive and negative predictive value were defined in the literature with a tumor/striatum threshold of 1. According to the latest and current European recommendations, turning to PET when caring for high-level gliomas patients can be proposed in the evaluation of therapeutic responses. However, very few studies have evaluated the in-practice current clinical contributions of PET and put it into perspective with classic clinical radiological data.

Conditions

Glioma; Cerebral Metastases

Outcome Measures

Primary Outcomes (1)

• confidence level in the therapeutic decision regarding the results from PET 18F-FDOPA imagery, in comparison with MRI alone.

  1 year up to 2 years

Secondary Outcomes (2)

• Validation of the decision taken with knowledge of the results from the PET 18F-FDOPA for post-operated patients

  1 year up to 2 years

• evaluation of PET 18F-FDOPA contribution according to clinical situations

  1 year up to 2 years

Study Arms (1)

PET 18FDOPA

OTHER

PET 18FDOPA

Other: PET 18FDOPA

Interventions

PET 18FDOPA OTHER

contribution of PET 18FDOPAimagery in high level glioma diagnosis

PET 18FDOPA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a historically proven high level of glimoa or of cerebral metastases
• Patients who have their files presented in a neurological oncologic CMM in one of the following situations:
• Diagnosis doubt between radionecrosis and tumor progression
• Evaluation at the end of the radio and chemotherapy period
• Evaluation under anti-angiogenic 18 years or older Patients who have been informed and have signed the consent form indicated in the study Patients with insurance coverage

You may not qualify if:

• Patients for whom having an MRI or a PET 18F-FDOPA would be contraindicated in light of any co-morbidities or allergies that it reveals

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Humbert O, Bourg V, Mondot L, Gal J, Bondiau PY, Fontaine D, Saada-Bouzid E, Paquet M, Chardin D, Almairac F, Vandenbos F, Darcourt J. 18F-DOPA PET/CT in brain tumors: impact on multidisciplinary brain tumor board decisions. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):558-568. doi: 10.1007/s00259-018-4240-8. Epub 2019 Jan 5.

  PMID: 30612162 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jacques DARCOURT, phd

  Centre Antoine Lacassagne

  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: November 19, 2013
• First Posted: December 30, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)