Molecular Imaging of HER2 Expression in HER2-positive Breast Cancer Using 99mTc-ADAPT6 vs 99mTc-DARPinG3

Breast Cancer Female Clinical Trial

Official title:

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Using 99mTc-ADAPT6 and 99mTc-DARPinG3 in HER2-positive Breast Cancer Patients Before System (Chemo/Targeted) Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376644
• Other study ID #: 99mTc-ADAPT6 vs 99mTc-DARPinG3
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 21, 2023

Study information

• Verified date: April 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients.

Description:

The primary objectives are: Compare SPECT/CT imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 in HER2-positive primary tumour of breast cancer patients before system (chemo/targeted) therapy. The secondary objectives are: To compare the SPECT/CT tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 21, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is > 18 years of age;

2. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy);

3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive;

4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient;

5. 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

6. 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. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. 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 -

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Drug:
• 99mTc-ADAPT6
One single injection of 99mTc-ADAPT6, followed by gamma camera imaging 2 hours after injection.
• 99mTc-DARPinG3
One single injection of 99mTc-DARPinG3, followed by gamma camera imaging 4 hours after injection.

Locations

Country	Name	City	State
Russian Federation	Tomsk NRMC	Tomsk

Sponsors (2)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences	Uppsala University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	99mTc-ADAPT6 uptake (counts)/SUV	SPECT/CT-based 99mTc-ADAPT6 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 hours after injection and measured in counts and SUV.	2 hours
Primary	99mTc-ADAPT6 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 (counts/SUV) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (counts)	2 hours
Primary	99mTc-DARPinG3 uptake (counts)/SUV	SPECT/CT-based 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 4 hours after injection and measured in counts and SUV	4 hours
Primary	99mTc-DARPinG3 tumor-to-background ratio (SPECT)	The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)	4 hours
Primary	99mTc-ADAPT6 vs 99mTc-DARPinG3 uptake (counts)/SUV	Comparison of SPECT/CT-based 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake value in primary tumor lesions (counts)/SUV of 99mTc-ADAPT6 and 99mTc-DARPinG3 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2 and 4 hours after injection and measured in counts and SUV.	2 and 4 hours
Primary	99mTc-ADAPT6 vs 99mTc-DARPinG3 tumor-to-background ratio (SPECT)	Comparison of the value of 99mTc-ADAPT6 versus 99mTc-DARPinG3 uptake coinciding with tumor lesions (counts/SUV) divided by the value of 99mTc-ADAPT6 and 99mTc-DARPinG3 uptake coinciding with the regions without pathological findings (counts/SUV)	2 and 4 hours
Secondary	99mTc-ADAPT6 vs immunohistochemical studies (percent)	Sensitivity (%) of the method is assessed by comparing the 99mTc-ADAPT6 accumulation in the primary tumor with the results of immunohistochemical studies	2 hours
Secondary	99mTc-DARPinG3 vs immunohistochemical studies (percent)	Sensitivity (%) of the method is assessed by comparing the 99mTc-DARPinG3 accumulation in the primary tumor with the results of immunohistochemical studies	4 hours