In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas (RADIOSUCCES)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Paraganglioma of Head and Neck

Treatments: Diagnostic Test: 1H-Spectroscopy MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04583384

APHP200281

2020-A00397-32 (Other Identifier)

Details and patient eligibility

About

Qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. We aim at assessing the added value of 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

Full description

Paragangliomas (PGL) are rare neuroendocrine tumors inherited in 40% of cases. SDHx genes (SDHA, SDHB, SDHC, SDHD), encoding the 4 subunits of the mitochondrial enzyme succinate dehydrogenase (SDH), are the most frequently involved.

Accumulation of succinate, the substrate for SDH, is a very specific biomarker for these mutations. Recently, we have demonstrated the feasability of detecting and quantifying succinate in tumors in vivo, by magnetic resonance spectroscopy (1H-SRM).

Patients carrying these mutations frequently develop cervical PGL for which the treatment of choice is external beam radiation therapy (EBR).

The objective of this project is to determine the feasibility of using 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Assigned Intervention

Other group

Description:

Addition to the cervical angio-MRI, of a sequence of 1H-SRM 3T (SUCCESS) centered on the lesion studied, performed according to the following parameters: PRESS asymmetric monovoxel "PROBE", TE 144 ms, TR 2500 ms, 768 or 1024 medium.

Treatment:

Diagnostic Test: 1H-Spectroscopy MRI