Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264778
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-08
Brief Title:
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma
Sponsor:
Shandong University
Organization:
Shandong University
Study Overview
Official Title:
Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence reducing or even avoiding postoperative deformity and dysfunction effect Based on this we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma and provide patients with a safer Effective new treatment options will benefit more patients
Detailed Description:
Main purpose
To verify the application value of dabrafenib a targeted drug targeting BRAF V600E mutation combined with fenestration decompression and tumor curettage therapy in the treatment of multicystic ameloblastoma It is expected to provide patients with a new treatment option that improves curative effect reduces postoperative tumor recurrence and avoids postoperative deformity
Secondary purpose
Study of regional heterogeneity in BRAF V600E-mutant ameloblastoma Provide new ideas for finding other effective treatments
Overall research design This study is a single-center single-arm exploratory study It is planned to enroll 10 patients with BRAF V600E mutation-positive multicystic ameloblastoma After signing the informed consent form you can enter the study as a subject
Subjects will receive the study drug dabrafenib immediately after window decompression surgery They will take dabrafenib for at least 8 weeks Lesion curettage will be performed within the 8th to 9th week Preoperative imaging will check the tumor volume zoomed out situation Patients whose lesions are not completely curettaged may choose to resume the dose of dabrafenib they received immediately before surgery
To verify the application value of dabrafenib a targeted drug targeting BRAF V600E mutation combined with fenestration decompression and tumor curettage therapy in the treatment of multicystic ameloblastoma It is expected to provide patients with a new treatment option that improves curative effect reduces postoperative tumor recurrence and avoids postoperative deformity
Secondary purpose
Study of regional heterogeneity in BRAF V600E-mutant ameloblastoma Provide new ideas for finding other effective treatments
Overall research design This study is a single-center single-arm exploratory study It is planned to enroll 10 patients with BRAF V600E mutation-positive multicystic ameloblastoma After signing the informed consent form you can enter the study as a subject
Subjects will receive the study drug dabrafenib immediately after window decompression surgery They will take dabrafenib for at least 8 weeks Lesion curettage will be performed within the 8th to 9th week Preoperative imaging will check the tumor volume zoomed out situation Patients whose lesions are not completely curettaged may choose to resume the dose of dabrafenib they received immediately before surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None