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99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes (99mTc-ADAPT6)

Primary Purpose

Breast Cancer, Female

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
ADAPT6-SPECT
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring 99mTc-ADAPT6, Breast Cancer, metastatic lymph nodes, HER2 expression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Diagnosis of primary breast cancer with lymph node metastases
  3. Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative

  4. Hematological, liver and renal function test results within the following limits:

    • White blood cell count: > 2.0 x 109/L
    • Hemoglobin: > 80 g/L
    • Platelets: > 50.0 x 109/L
    • ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
    • Bilirubin =< 2.0 times Upper Limit of Normal
    • Serum creatinine: Within Normal Limits
  5. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination

7. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent

Exclusion Criteria:

  1. Any system therapy (chemo-/targeted therapy)
  2. Second, non-breast malignancy
  3. Active current autoimmune disease or history of autoimmune disease
  4. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
  5. Administration of other investigational medicinal product within 30 days of screening
  6. Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sites / Locations

  • Tomsk NRMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HER2-positive patients

HER2-negative patients

Arm Description

Maximum 15 evaluable subjects with HER2-positive status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.

Maximum 15 evaluable subjects with HER2-negative status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.

Outcomes

Primary Outcome Measures

SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV)
SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV
SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV)
SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV
Tumor-to-background ratio (SPECT)
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)
LN-to-background LN ratio (SPECT)
The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with LN lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)

Secondary Outcome Measures

Matching test rate (percentage)
Comparison of the 99mTc-ADAPT6 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies.

Full Information

First Posted
June 2, 2022
Last Updated
April 19, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05412446
Brief Title
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes
Acronym
99mTc-ADAPT6
Official Title
SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Primary Tumour and Metastatic Axillary Lymph Nodes Using Technetium-99m-labelled ADAPT6 Molecule-based 99mTc-ADAPT6.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborators
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and standard histopathology from relevant tumor and lymph node biopsies.
Detailed Description
Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before neoadjuvant targeted (trastuzumab or trastuzumab+pertuzumab) therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Female
Keywords
99mTc-ADAPT6, Breast Cancer, metastatic lymph nodes, HER2 expression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HER2-positive patients
Arm Type
Experimental
Arm Description
Maximum 15 evaluable subjects with HER2-positive status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.
Arm Title
HER2-negative patients
Arm Type
Experimental
Arm Description
Maximum 15 evaluable subjects with HER2-negative status in primary tumour before chemo/targeted therapy have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced.
Intervention Type
Drug
Intervention Name(s)
ADAPT6-SPECT
Other Intervention Name(s)
Diagnostic ADAPT6-SPECT injection
Intervention Description
Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Primary Outcome Measure Information:
Title
SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions (SUV)
Description
SPECT/CT-based 99mTc-ADAPT6 uptake value in tumor lesions measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV
Time Frame
2 hours
Title
SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes (SUV)
Description
SPECT/CT-based 99mTc-ADAPT6 uptake value in metastatic lymph nodes SUV measured as 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in SUV
Time Frame
2 hours
Title
Tumor-to-background ratio (SPECT)
Description
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)
Time Frame
2 hours
Title
LN-to-background LN ratio (SPECT)
Description
The SPECT-based LN-to-background LN ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with LN lesions (SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (SUV)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Matching test rate (percentage)
Description
Comparison of the 99mTc-ADAPT6 accumulation in the primary tumor and metastatic lymph nodes with the results of morphological and immunohistochemical studies.
Time Frame
2 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is > 18 years of age Diagnosis of primary breast cancer with lymph node metastases Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative Hematological, liver and renal function test results within the following limits: White blood cell count: > 2.0 x 109/L Hemoglobin: > 80 g/L Platelets: > 50.0 x 109/L ALT, ALP, AST: =< 5.0 times Upper Limit of Normal Bilirubin =< 2.0 times Upper Limit of Normal Serum creatinine: Within Normal Limits A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination 7. Subject is capable to undergo the diagnostic investigations to be performed in the study 8. Informed consent Exclusion Criteria: Any system therapy (chemo-/targeted therapy) Second, non-breast malignancy Active current autoimmune disease or history of autoimmune disease Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C Administration of other investigational medicinal product within 30 days of screening Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir I Chernov, MD, PhD
Organizational Affiliation
Caencer Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Tomsk NRMC
City
Tomsk
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes

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