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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04583384
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laurence AMAR, PhD
Principal Investigator Affiliation Hôpital Européen Georges-Pompidou
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Paraganglioma of Head and Neck
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Diagnostic Test: - 1H-Spectroscopy MRI

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

Contact a Trial Team

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International Sites

Hôpital Lariboisière, Paris, France

Status

Recruiting

Address

Hôpital Lariboisière

Paris, , 75010

Site Contact

Philippe HERMAN, Dr

[email protected]

+33147711111

Hôpital Pitié-Salpêtrière, Paris, France

Status

Recruiting

Address

Hôpital Pitié-Salpêtrière

Paris, , 75013

Site Contact

Charlotte LUSSEY-LEPOUTRE, Dr

[email protected]

+33142178370

Hopital européen Georges Pompidou, Paris, France

Status

Recruiting

Address

Hopital européen Georges Pompidou

Paris, , 75015

Site Contact

Laurence AMAR, PhD

[email protected]

+33156093771

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