Paraganglioma of Head and NeckRADIOSUCCESNCT04583384
In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas
A study testing 1H-Spectroscopy MRI in people with Paraganglioma of Head and Neck, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraganglioma of Head and Neck
- What is being tested?
- 1H-Spectroscopy MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 27 Oct 2020to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Lariboisière
Paris, 75010
Philippe HERMAN, Dr, +33147711111, philippe.herman@aphp.fr
- Recruiting
Hôpital Pitié-Salpêtrière
Paris, 75013
Charlotte LUSSEY-LEPOUTRE, Dr, +33142178370, charlotte.lussey@inserm.fr
- Recruiting
Hopital européen Georges Pompidou
Paris, 75015
Laurence AMAR, PhD, +33156093771, laurence.amar@aphp.fr
About this study
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
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.
Read the 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.
- Conditions
- Paraganglioma of Head and Neck
- Being tested
- 1H-Spectroscopy MRI
- Keywords
- Paraganglioma,SDHx genes, 1H-Spectroscopy MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1H-Spectroscopy MRIDiagnostic test
PRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 1H-Spectroscopy MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 3 months
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
Measured: 12 months
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
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start27 Oct 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraganglioma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Endocrinology
- Responsible party
- Sponsor
- Investigators
- Laurence AMAR, PhD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583384
- Sponsor's protocol ID
- APHP200281
- Other IDs
- 2020-A00397-32
- Acronym
- RADIOSUCCES
- Status last verified
- Dec 2021
- First submitted
- 5 Oct 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04583384
- Acronym / sponsor ID
- RADIOSUCCES / APHP200281
- Conditions
- Paraganglioma of Head and Neck
- Keywords
- Paraganglioma,SDHx genes, 1H-Spectroscopy MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Society for Endocrinology
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Intervention | Other | Diagnostic Test: 1H-Spectroscopy MRIAddition 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1H-Spectroscopy MRIPRESS asymetric monovoxel " PROBE ", TE 144 ms, TR 2500 ms, 768 or 1024 averages | Diagnostic test | Assigned Intervention |
Primary outcome
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.
4 secondary outcomes
Disapperance of succinate accumulation at M3
Time frame: 3 months
Performance of cervical MRI at M3 and M12 after EBR
Time frame: 12 months
Performance of PET/CT at M12 after EBR
Time frame: 12 months
Metastatic evolution or death at M12
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence AMAR, PhD principal investigator
Hôpital Européen Georges-Pompidou
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1H-Spectroscopy MRI in people with Paraganglioma of Head and Neck, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte LUSSEY-LEPOUTRE, PhD (+33142178370, charlotte.lussey@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of succinate accumulation at M12 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.