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NCT02296216: LateRAc
Late Effects of Radiosurgery on Acromegaly Study
NA trial testing Gamma Knife radiosurgery in Acromegaly in 66 participants. Completed in 13 April 2023.
17 December 2017
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 66 |
| Start date | 16 February 2015 |
| Primary completion | 17 December 2017 |
| Estimated completion | 13 April 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Gamma Knife radiosurgery
Conditions studied
- Acromegaly — all drugs for Acromegaly →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
18 and older, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02296216
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gamma Knife radiosurgery
Trials testing the same drug.
- NCT04857905 — Dose-staged Gamma Knife Radiosurgery Versus Microsurgical Resection · NA · unknown
- NCT01284699 — Evaluation of the Safety and Efficacy of Bilateral Subthalamic Nucleus (SNT) Radiosurgery in Idiopathic Severe Parkinson · NA · completed
Other recruiting trials for Acromegaly
Currently open trials in the same condition.
- NCT07037420 — ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly · Phase 2 · recruiting
- NCT05401084 — Diet in the Management of Acromegaly · NA · recruiting
- NCT05131100 — Korean Regulatory Post Marketing Surveillance for Somavert · recruiting
- NCT05964712 — Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study · recruiting
- NCT03158090 — The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research · recruiting
Other Assistance Publique Hopitaux De Marseille trials
Trials by the same sponsor.
- NCT07521644 — Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome · NA · not yet recruiting
- NCT07357025 — Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia · NA · not yet recruiting
- NCT07356661 — Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients · NA · not yet recruiting
- NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation · NA · not yet recruiting
- NCT06999499 — Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02296216 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 18 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02296216.
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