Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02296216
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2014-10-28
Brief Title:
Late Effects of Radiosurgery on Acromegaly Study
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
LateR-Ac Study Late Effects of Radiosurgery on Acromegaly Study
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LateRAc
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 exposedunexposed 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 patientsgroup 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
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 exposedunexposed 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 patientsgroup 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RCAPHM14_0079 | REGISTRY | APHM | None |