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

NCT ID: NCT04583384

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Paraganglioma of Head and Neck

Keywords

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Paraganglioma,SDHx genes, 1H-Spectroscopy MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

1H-Spectroscopy MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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1H-Spectroscopy MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society for Endocrinology

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence AMAR, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen Georges-Pompidou

Locations

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Hôpital Lariboisière

Paris, , France

Site Status RECRUITING

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status RECRUITING

Hopital européen Georges Pompidou

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Charlotte LUSSEY-LEPOUTRE, PhD

Role: CONTACT

Phone: +33142178370

Email: [email protected]

Malha BERRAH, MSc

Role: CONTACT

Phone: +33156095822

Email: [email protected]

Facility Contacts

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Philippe HERMAN, Dr

Role: primary

Charlotte LUSSEY-LEPOUTRE, Dr

Role: primary

Laurence AMAR, PhD

Role: primary

Other Identifiers

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2020-A00397-32

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200281

Identifier Type: -

Identifier Source: org_study_id