Clinical trial NCT04583384: In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paraganglioma of Head and Neck
Keywords: Paraganglioma,SDHx genes, 1H-Spectroscopy MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Society for Endocrinology
First posted: 2020-10-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Disappearance of succinate accumulation at M12
timeFrame: 12 months
Secondary outcomes:
measure: Disapperance of succinate accumulation at M3
timeFrame: 3 months
measure: Performance of cervical MRI at M3 and M12 after EBR
timeFrame: 12 months
measure: Performance of PET/CT at M12 after EBR
timeFrame: 12 months
measure: Metastatic evolution or death at M12
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hopital européen Georges Pompidou
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Laurence AMAR, PhD
role: PRINCIPAL_INVESTIGATOR
References: