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

NCT04583384 | Unknown

• 2 other identifiers: APHP2002812020-A00397-32
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Paraganglioma of Head and Neck

Keywords

Paraganglioma,SDHx genes, 1H-Spectroscopy MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disapperance of succinate accumulation at M3

  3 months

• Performance of cervical MRI at M3 and M12 after EBR

  12 months

• Performance of PET/CT at M12 after EBR

  12 months

• Metastatic evolution or death at M12

  12 months

Study Arms (1)

Assigned Intervention

OTHER

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.

Diagnostic Test: 1H-Spectroscopy MRI

Interventions

1H-Spectroscopy MRI DIAGNOSTIC_TEST

PRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages

Assigned Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Society for Endocrinology: collaborator

Study Sites (3)

Hôpital Lariboisière

Paris, 75010, France

RECRUITING

Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Hopital européen Georges Pompidou

Paris, 75015, France

RECRUITING

Study Officials

• Laurence AMAR, PhD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte LUSSEY-LEPOUTRE, PhD

CONTACT

+33142178370; charlotte.lussey@inserm.fr

Malha BERRAH, MSc

CONTACT

+33156095822; malha.berrah@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: October 27, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2025
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization

Locations

FR (3)