NCT07017790

Brief Summary

Amino acid PET imaging could represent a biomarker for the evaluation of IDH inhibitor treatments for patients with refractory IDH-mutated gliomas

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1 day

First QC Date

June 4, 2025

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compare the performance between amino acid PET and brain MRI to assess a treatment efficacy

    Comparison between early therapeutic response according to RANO 1.0 and RANO 2.0 PET criteria and tumor progression at 6 months

    one day

Secondary Outcomes (1)

  • Compare the performance between amino acid PET and brain MRI to assess a treatment efficacy for the identification of lesions

    one day

Interventions

Patients received 18-fluoroDopa then a PET exam

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent amino acid PET for early assessment of therapeutic response of IDH-mutated gliomas under anti-IDH treatment between February 2022 and November 2024

You may qualify if:

  • Patients who underwent amino acid PET for early assessment of therapeutic response of IDH-mutated gliomas under anti-IDH treatment between February 2022 and November 2024

You may not qualify if:

  • Individuals who have objected to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU of NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Central Study Contacts

Antoine VERGER, MD,PhD

CONTACT

Véronique ROCH, MsC

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

June 30, 2025

Primary Completion

July 1, 2025

Study Completion

August 30, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations