Detecting succinate levels in paragangliomas after radiation therapy
Evolution of Succinate Accumulation Detected in Vivo by Spectroscopic Magnetic Resonance Imaging (1H-SRM) After External Beam Radiation Therapy in SDHx-mutated Patients With Cervical Paragangliomas
This study is testing if a special type of MRI can help find levels of succinate in patients with cervical paragangliomas after they receive radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Paris and 2 other locations) |
| Trial ID | NCT04583384 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of 1H-Spectroscopy MRI in detecting succinate levels in patients with cervical paragangliomas who are undergoing external beam radiation therapy. Paragangliomas are rare tumors often associated with mutations in SDHx genes, which lead to succinate accumulation. By assessing succinate as a biomarker, the study seeks to determine the early response to radiation therapy in these patients. The research will involve patients aged 18 and older who have been diagnosed with cervical paragangliomas and are planning to receive radiation treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with cervical paragangliomas and known or suspected SDHx mutations who are scheduled for external beam radiation therapy.
Not a fit: Patients who have previously received local or systemic treatment for their paragangliomas or those with contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for monitoring treatment response in patients with cervical paragangliomas.
How similar studies have performed: While the approach of using succinate as a biomarker in this context is innovative, similar studies have shown promise in utilizing metabolic imaging for tumor assessment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Signed informed consent * Patient with cervical PGL with planning of treatment with EBR * Patient with an SDHx mutation or unknown genetic status * Patient affiliated to a social security scheme Exclusion Criteria: * Pregnant woman * Contraindication to MRI (implantable device, etc.) * Impossibility of lying down without movement for 45 minutes (hyperalgesic patient, claustrophobia, etc.) * PPGL having previously been the subject of local (excluding surgery) or systemic treatment * PPGL \<1 cm longest axis * Patient under guardianship or curatorship
Where this trial is running
Paris and 2 other locations
- Hôpital Lariboisière — Paris, France (Recruiting)
- Hôpital Pitié-Salpêtrière — Paris, France (Recruiting)
- Hopital européen Georges Pompidou — Paris, France (Recruiting)
Study contacts
- Principal investigator: Laurence AMAR, PhD — Hôpital Européen Georges-Pompidou
- Study coordinator: Charlotte LUSSEY-LEPOUTRE, PhD
- Email: charlotte.lussey@inserm.fr
- Phone: +33142178370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.