Back to resultsLate Effects of Radiosurgery on Acromegaly Study (LateRAc)
Primary Purpose
Acromegaly
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gamma Knife radiosurgery
Sponsored by
About this trial
This is an interventional other trial for Acromegaly focused on measuring have been treated or not treated by Gamma Knife Radiosurgery
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Exposed patients
Unexposed patients
Arm Description
Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion
Unexposed patients have not been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02296216
First Posted
October 28, 2014
Last Updated
April 13, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02296216
Brief Title
Late Effects of Radiosurgery on Acromegaly Study
Acronym
LateRAc
Official Title
LateR-Ac Study: Late Effects of Radiosurgery on Acromegaly Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2015 (Actual)
Primary Completion Date
December 17, 2017 (Actual)
Study Completion Date
April 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
have been treated or not treated by Gamma Knife Radiosurgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposed patients
Arm Type
Active Comparator
Arm Description
Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion
Arm Title
Unexposed patients
Arm Type
Placebo Comparator
Arm Description
Unexposed patients have not been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion
Intervention Type
Device
Intervention Name(s)
Gamma Knife radiosurgery
Intervention Description
To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly
Primary Outcome Measure Information:
Title
The cognitive assessment measure a subject as cognitively preserved or cognitively impaired
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Late Effects of Radiosurgery on Acromegaly Study
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