Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390241
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-17
Brief Title:
Avidination for RadionuclideTHerapy in Nonpalpable Breast Cancer
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Avidination for Radionuclide THerapy ARTHE in Nonpalpable Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ARTHE
Brief Summary:
This is an interventional open-label non comparative phase 2 trial enrolling patients with nonpalpable breast cancer
Detailed Description:
Nonpalpable breast lesions NPBLs represent approximately 30 of the overall tumoral breast lesions undergoing surgery The Vacuum-Assisted Breast Biopsy VABB is a device for needle breast biopsy usefully applied in NPBL The procedure is highly effective for the diagnosis of NPBLs with minimal negative effects The specimen volume obtained through this procedure is great enough to replace the diagnostic surgical excisional biopsy and frozen section intraoperative examination Biopsies obtained through this method sometimes allow the complete excision of the lesion representing a valid alternative to the excisional biopsy in case of benign lesion less than 15 mm in size
After VABB procedure about 10-30 of patients have a complete removal of the neoplastic lesion About 30 of patients are disease free after surgery because the lesion has been totally removed through diagnostic VABB procedure The rationale of this project is to treat residual microscopic disease through a radionuclide therapy Our idea is to administer following VABB procedure an avidin-biotin-DOTA-90Y where DOTA stands for 14710-tetra-azacyclododecane-NNNN-tetraacetic acid and Y stands for yttrium compound into the lesion site in order to eliminate residual tumour cells The ARTHE approach should increase the rate of disease free cases after excisional biopsy
The primary objective of this open-label phase I trial is to evaluate the safety of avidin-biotin-DOTA-90Y combination in patients with nonpalpable breast cancer undergoing Vacuum-Assisted- Breast- Biopsy VABB The co-primary objective is the evaluation of the preliminary anti-tumor activity of the treatment The secondary objective is to evaluate the dosimetry and biodistribution of avidin-biotin-DOTA-90Y after loco-regional injection under ultrasound guidance
ARTHE procedure consists of the ultrasound guided injection of Avidin into the breast tissue corresponding to VABB site followed by an injection of Biotin-DOTA-90Y The injected Biotin-DOTA-90Y will be in a range 28-126 MBq megabecquerel 02- 03 mL specific activity of 37 GBqmg gigabequerelmilligrams The investigators will inject 6-10 mg of avidin in a volume of 03-05 mL followed by biotin-DOTA-90Y immediately after avidin injection
The hypothesis that a treatment with avidin-biotin-DOTA-90Y is able to destroy residual cancer cells after VABB will be verified by surgery
The duration of ARTHE procedure is 3 days including dosimetry evaluation Patients will receive conservative surgical treatment 4-7 weeks from ARTHE treatment
After VABB procedure about 10-30 of patients have a complete removal of the neoplastic lesion About 30 of patients are disease free after surgery because the lesion has been totally removed through diagnostic VABB procedure The rationale of this project is to treat residual microscopic disease through a radionuclide therapy Our idea is to administer following VABB procedure an avidin-biotin-DOTA-90Y where DOTA stands for 14710-tetra-azacyclododecane-NNNN-tetraacetic acid and Y stands for yttrium compound into the lesion site in order to eliminate residual tumour cells The ARTHE approach should increase the rate of disease free cases after excisional biopsy
The primary objective of this open-label phase I trial is to evaluate the safety of avidin-biotin-DOTA-90Y combination in patients with nonpalpable breast cancer undergoing Vacuum-Assisted- Breast- Biopsy VABB The co-primary objective is the evaluation of the preliminary anti-tumor activity of the treatment The secondary objective is to evaluate the dosimetry and biodistribution of avidin-biotin-DOTA-90Y after loco-regional injection under ultrasound guidance
ARTHE procedure consists of the ultrasound guided injection of Avidin into the breast tissue corresponding to VABB site followed by an injection of Biotin-DOTA-90Y The injected Biotin-DOTA-90Y will be in a range 28-126 MBq megabecquerel 02- 03 mL specific activity of 37 GBqmg gigabequerelmilligrams The investigators will inject 6-10 mg of avidin in a volume of 03-05 mL followed by biotin-DOTA-90Y immediately after avidin injection
The hypothesis that a treatment with avidin-biotin-DOTA-90Y is able to destroy residual cancer cells after VABB will be verified by surgery
The duration of ARTHE procedure is 3 days including dosimetry evaluation Patients will receive conservative surgical treatment 4-7 weeks from ARTHE treatment
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