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

December 20, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • Hopital Lariboisiere
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Hopital Europeen Georges Pompidou
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie-Salpetriere
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Assigned Intervention
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
PRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance of succinate accumulation at M12
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disapperance of succinate accumulation at M3
Time Frame: 3 months
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
Performance of cervical MRI at M3 and M12 after EBR
Time Frame: 12 months
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
Performance of PET/CT at M12 after EBR
Time Frame: 12 months
PERCIST criteria (PET response criteria in solid tumors) assessed by PET/CT at 3 months and 12 months after EBR
12 months
Metastatic evolution or death at M12
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Society for Endocrinology

Investigators

  • Principal Investigator: Laurence AMAR, PhD, Hôpital Européen Georges-Pompidou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 27, 2020

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (ACTUAL)

October 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200281
  • 2020-A00397-32 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared.

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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