Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 12:48 PM
Study NCT ID:
NCT03991260
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2019-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Study Overview
Official Title:
SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
Status:
COMPLETED
Status Verified Date:
2020-07
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:
99mTc-ADAPT6
Brief Summary:
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. To assess kinetics of 99mTc- ADAPT6 in blood;
3. To evaluate dosimetry of 99mTc- ADAPT6;
4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
The primary objective are:
1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. To assess kinetics of 99mTc- ADAPT6 in blood;
3. To evaluate dosimetry of 99mTc- ADAPT6;
4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
Detailed Description:
Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.
Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. To assess kinetics of 99mTc- ADAPT6 in blood;
3. To evaluate dosimetry of 99mTc- ADAPT6;
4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
1\. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.
Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
1. To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. To assess kinetics of 99mTc- ADAPT6 in blood;
3. To evaluate dosimetry of 99mTc- ADAPT6;
4. To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
1\. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:
Methodology:
Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 99mTc-ADAPT6 [TomskNRMC] | OTHER | TomskNRMC | View |