AcromegalyLateRAcNCT02296216
Late Effects of Radiosurgery on Acromegaly Study
A study testing Gamma Knife radiosurgery in people with Acromegaly, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Gamma Knife radiosurgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2015to 13 Apr 2023
- 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
- Subject, man or woman, whose age is greater than or equal to 18 years;
- Subject has a combination of defined values plus Insulin Like Growth Factor-1 and no braking growth hormone (<1.2 milli-International unit/L) during an oral glucose tolerance acromegaly.
- Exposed: Subject with a surgically treated in remission with or without drug treatment somatostatinergic, acromegaly who received treatment with Gamma Knife radiosurgery within not less than 10 years and less than or equal to 20 years.
- Not exposed: Subject with a surgically treated acromegaly controlled by treatment somatostatinergic, not having received Gamma Knife radiosurgery.
- Subjects with thyroid under standardized assessment Levothyrox® inclusion in case of deficit associated thyroid stimulating;
- Topic supported in a project partner services;
- Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol.
Who cannot join
- Minor or over the age of 75 years subject,
- Subjects with acromegaly resistant to somatostatinergic, or that required power is pegvisomant or cabergoline
- Subjects who received two pituitary neurosurgical treatment or treatment with conventional radiotherapy or radiosurgery treatments 2
- Pregnant or lactating woman,
- Topic is not affiliated with the social security system, or private about freedom;
- Subject refusing to participate in the study or not signing the informed consent;
- Subject with malignant disease known evolutionary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly.
Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.
Read more
Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.
Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.
- Conditions
- Acromegaly
- Being tested
- Gamma Knife radiosurgery
- Keywords
- have been treated or not treated by Gamma Knife Radiosurgery
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Knife radiosurgeryDevice
To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly
| Study group | Role | What they receive |
|---|---|---|
| Exposed patients | Active comparator | Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion Receives: Device: Gamma Knife radiosurgery |
| Unexposed patients | Placebo comparator | Unexposed patients have not been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion Receives: Device: Gamma Knife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cognitive assessment measure a subject as cognitively preserved or cognitively impaired
Assessment of cognitive functions based on:
- Evaluation of the memory component : Test Grober and Buschke.
- Cognitive functions : Tests Stroop and Trail making test.
- Evaluation of the care component and concentration : Paced Auditory Serial Addition Test.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start16 Feb 2015
- Primary completion17 Dec 2017
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296216
- Sponsor's protocol ID
- 2014-08
- Other IDs
- RCAPHM14_0079
- Acronym
- LateRAc
- Status last verified
- Apr 2023
- First submitted
- 28 Oct 2014
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study
- ClinicalTrials.gov ID
- NCT02296216
- Acronym / sponsor ID
- LateRAc / 2014-08
- Conditions
- Acromegaly
- Keywords
- have been treated or not treated by Gamma Knife Radiosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 Feb 2015 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 20 Nov 2014 (estimated)
- 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.
Transsphenoidal surgery is the first-line treatment of acromegaly. Adjunctive radiotherapy can be necessary when surgery is ineffective to avoid a prolonged medical treatment. Several studies reported long-term extra-pituitary side-effects of conventional radiotherapy. However, none has evaluated potential side-effects induced by Gamma Knife radiosurgery, a highly precise stereotactic technique, that has been used as an effective treatment of acromegaly.
Aims of the study: To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly.
Methods: Transversal exposed/unexposed study. Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion, whereas unexposed patients have been treated by somatostatin analogs after unsuccessful surgery for at least 10 years before inclusion. 80 Patients (40 patients/group) will be evaluated in terms of cognitive dysfunction, quality of life, secondary tumor, stroke, pituitary deficits and growth hormone control of hypersecretion. Recruitment is planned to last for 2 years.
Expected results: We should be able to determine whether Gamma Knife radiosurgery is a long-term safe technique. This result might modify the management and follow-up of patients with acromegaly unsuccessfully treated by surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed patients | Active comparator | Device: Gamma Knife radiosurgeryExposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion |
| Unexposed patients | Placebo comparator | Device: Gamma Knife radiosurgeryUnexposed patients have not been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject, man or woman, whose age is greater than or equal to 18 years;
- Subject has a combination of defined values plus Insulin Like Growth Factor-1 and no braking growth hormone (<1.2 milli-International unit/L) during an oral glucose tolerance acromegaly.
- Exposed: Subject with a surgically treated in remission with or without drug treatment somatostatinergic, acromegaly who received treatment with Gamma Knife radiosurgery within not less than 10 years and less than or equal to 20 years.
- Not exposed: Subject with a surgically treated acromegaly controlled by treatment somatostatinergic, not having received Gamma Knife radiosurgery.
- Subjects with thyroid under standardized assessment Levothyrox® inclusion in case of deficit associated thyroid stimulating;
Key exclusion criteria (7 listed)
- Minor or over the age of 75 years subject,
- Subjects with acromegaly resistant to somatostatinergic, or that required power is pegvisomant or cabergoline
- Subjects who received two pituitary neurosurgical treatment or treatment with conventional radiotherapy or radiosurgery treatments 2
- Pregnant or lactating woman,
- Topic is not affiliated with the social security system, or private about freedom;
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 |
|---|---|---|
| Gamma Knife radiosurgeryTo determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly | Device | Exposed patients, Unexposed patients |
Primary outcome
The cognitive assessment measure a subject as cognitively preserved or cognitively impaired
Time frame: 24 months
Assessment of cognitive functions based on: * Evaluation of the memory component : Test Grober and Buschke. * Cognitive functions : Tests Stroop and Trail making test. * Evaluation of the care component and concentration : Paced Auditory Serial Addition Test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
Urielle DESALBRES, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Knife radiosurgery in people with Acromegaly, run by Assistance Publique Hopitaux De Marseille at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cognitive assessment measure a subject as cognitively preserved or cognitively impaired (time frame: 24 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 18 Apr 2023.