Late Effects of Radiosurgery on Acromegaly Study

NCT02296216 | Completed

• 2 other identifiers: 2014-08RCAPHM14_0079
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Keywords

have been treated or not treated by Gamma Knife Radiosurgery

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Study Arms (2)

Exposed patients

ACTIVE COMPARATOR

Exposed patients have been treated by Gamma Knife Radiosurgery after unsuccessful surgery 10-20 years before inclusion

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

Device: Gamma Knife radiosurgery

Interventions

Gamma Knife radiosurgery DEVICE

To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly

Exposed patients; Unexposed patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Urielle DESALBRES, Director

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 20, 2014
• Study Start: February 16, 2015
• Primary Completion: December 17, 2017
• Study Completion: April 13, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

FR (1)