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

Paraganglioma of Head and Neck Clinical Trial

— RADIOSUCCES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583384
• Other study ID #: APHP200281
• Secondary ID: 2020-A00397-32
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: June 2025

Study information

• Verified date: December 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Charlotte LUSSEY-LEPOUTRE, PhD
• Phone: +33142178370
• Email: charlotte.lussey[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2025
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paraganglioma
• Paraganglioma of Head and Neck

Intervention

Diagnostic Test:
• 1H-Spectroscopy MRI
PRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages

Locations

Country	Name	City	State
France	Hopital européen Georges Pompidou	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Pitié-Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Society for Endocrinology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance of succinate accumulation at M12	Absence of succinate accumulation detected in vivo by 1H-SRM, in cervical PGLs with SDHx mutations, at 12 months after EBR, reviewed by 2 independant experts blinded to all other clinical and genetics data.	12 months
Secondary	Disapperance of succinate accumulation at M3	Absence of succinate accumulation detected in vivo by 1H-SRM, in cervical PGLs with SDHx mutations, at 3 months after EBR, reviewed by 2 independant experts blinded to all other clinical and genetics data.	3 months
Secondary	Performance of cervical MRI at M3 and M12 after EBR	Reference diagnostic for response assessed by MRI at 3 months and 12 months after EBR: 1/ Complete response : tumour disappearance ; 2/ Partial response : decrease by at least 30% of tumour volume and no clinical symptomatology worsening ; 3/ stable : stability of tumour size and no clinical symptomatology worsening; 4/ Progression : increase by at least 20% of tumour volume and/or clinical symptomatological worsening	12 months
Secondary	Performance of PET/CT at M12 after EBR	PERCIST criteria (PET response criteria in solid tumors) assessed by PET/CT at 3 months and 12 months after EBR	12 months
Secondary	Metastatic evolution or death at M12	Occurence of an event related to the disease during 12 months follow-up (metastatic evolution of the disease or death). Metastases diagnostic is assessed remotely by presence in chromaffin tissue (http://www.sfendocrino.org/article/599/recommandations)	12 months