Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT01858116
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2013-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Study of Breast Cancer Patients Using [68Ga]ABY-025
Sponsor:
Biomedical Radiation Sciences
Organization:
Study Overview
Official Title:
An Exploratory Study to Evaluate [68Ga]ABY-025 for PET Imaging of HER2 Expression in Subjects With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-01
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:
The study will evaluate \[68Ga\]ABY-025 for PET imaging of HER2 expression in subjects with HER2-positive or HER2-negative breast cancer.
Detailed Description:
Open-labeled, exploratory, single center study.
1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. \[68Ga\]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third \[68Ga\]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.
2. Group 2 Ten subjects with HER2-positive primary tumor status. \[68Ga\]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second \[68Ga\]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.
1. Group 1 (dose-finding) Six subjects with HER2-positive primary tumor status and four subjects with HER2-negative status. \[68Ga\]ABY-025 PET with low dose (100 μg) of ABY-025 peptide is performed, followed by a repeated PET within three weeks using high dose (500 μg) ABY-025 peptide (radioactivity maximum 500 MBq). A third \[68Ga\]ABY-025 PET will be performed in the HER2-positive subgroup only, when signs of progressive disease are found at routine clinical evaluation or else latest after 12 months regardless of disease status, then using the ABY-025 peptide dose previously determined to be preferable.
2. Group 2 Ten subjects with HER2-positive primary tumor status. \[68Ga\]ABY-025 PET is performed using the ABY-025 peptide dose determined to be preferable during the dose-finding part of the study, followed by a second \[68Ga\]ABY-025 PET investigation at signs of progressive disease or else latest after 9 months.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-005228-14 | EUDRACT_NUMBER | None | View |