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Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

Primary Purpose

Breast Cancer Female

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

SPECT

About this trial

This is an interventional diagnostic trial for Breast Cancer Female focused on measuring 99mTc-ZHER2:41071, Breast Cancer, HER2 expression

Eligibility Criteria

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

Inclusion Criteria:

Subject is > 18 years of age
Diagnosis of primary breast cancer with possible lymph node metastases
Availability of results from HER2 status previously determined on material from the primary tumor, either
1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 2.0 cm in greatest diameter outside of the liver and kidneys
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
Subject is capable to undergo the diagnostic investigations to be performed in the study
Informed consent

Exclusion Criteria:

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)
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

Sites / Locations

TomskNRMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

The tested injected doses of 99mTc-ZHER2:41071 500 μg

The tested injected doses of 99mTc-ZHER2:41071 1000 μg

Arm Description

At least five (5) evaluable subjects with HER2-positive status and at least five (5) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. Subjects withdrawn from the study for any reason will be replaced.

Outcomes

Primary Outcome Measures

Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)

Whole-body 99mTc-ZHER2:41071 uptake coinciding with normal organs and tissues will be assessed using gamma camera at 2, 4, 6 and 24 hours after injection and calculated as percentage (%) of the injected dose of the radiopharmaceutical

SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV

99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV

SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV

Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.

Tumor-to-background ratio (SPECT)

The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ZHER2:41071 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ZHER2:41071 uptake coinciding with the regions without pathological findings (kcounts)

Secondary Outcome Measures

Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)

Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)

Safety attributable to 99mTc-ZHER2:41071 injections (ECG )

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)

Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the blood laboratory tests (% of cases with abnormal findings relative to baseline)

Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the urine laboratory tests (% of cases with abnormal findings relative to baseline)

Safety attributable to 99mTc-ZHER2:41071 injections (incidence and severity of adverse events)

The safety attributable to 99mTc- ZHER2:41071 injections will be evaluated based on the rate of adverse events (%)

Safety attributable 99mTc-ZHER2:41071 injections (concomitant medication)

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the rate of administration of concomitant medication (%)

Full Information

NCT ID

NCT05203497

First Posted

December 30, 2021

Last Updated

April 19, 2023

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05203497

Brief Title

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

Official Title

SPECT Imaging of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Using Technetium-99m-labelled Affibody Molecule-based Tracer 99mTc-ZHER2:41071.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 22, 2021 (Actual)

Primary Completion Date

March 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are: To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time; To evaluate dosimetry of 99mTc-ZHER2:41071; To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection: The secondary objectives are: 1. To compare the tumor imaging data with the data concerning HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (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 targeted (trastuzumab or trastuzumab+pertuzumab) therapy. Phase I. Distribution of 99mTc-ZHER2:41071 in patients with primary breast cancer. The study should evaluate distribution of 99mTc-ZHER2:41071 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objectives are: To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time; To evaluate dosimetry of 99mTc-ZHER2:41071; To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection: The secondary objectives are: 1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) analysis of biopsy samples: Methodology: Open-label, exploratory, single center study. The subjects will receive a single injection of the labelled tracer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Female

Keywords

99mTc-ZHER2:41071, Breast Cancer, HER2 expression

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The tested injected doses of 99mTc-ZHER2:41071 500 μg

Arm Type

Experimental

Arm Description

Arm Title

The tested injected doses of 99mTc-ZHER2:41071 1000 μg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

SPECT

Other Intervention Name(s)

99mTc-ZHER2:41071

Intervention Description

One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Primary Outcome Measure Information:

Title

Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)

Description

Time Frame

24 hours

Title

SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV

Description

99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV

Time Frame

6 hours

Title

SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV

Description

Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.

Time Frame

6 hours

Title

Tumor-to-background ratio (SPECT)

Description

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of physical examination (% of cases with abnormal findings relative to baseline)

Time Frame

24 hours

Title

Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of vital signs (% of cases with abnormal findings relative to baseline)

Time Frame

24 hours

Title

Safety attributable to 99mTc-ZHER2:41071 injections (ECG )

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the assessments of ECG (% of cases with abnormal findings relative to baseline)

Time Frame

24 hours

Title

Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the blood laboratory tests (% of cases with abnormal findings relative to baseline)

Time Frame

24 hours

Title

Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the urine laboratory tests (% of cases with abnormal findings relative to baseline)

Time Frame

24 hours

Title

Safety attributable to 99mTc-ZHER2:41071 injections (incidence and severity of adverse events)

Description

The safety attributable to 99mTc- ZHER2:41071 injections will be evaluated based on the rate of adverse events (%)

Time Frame

24 hours

Title

Safety attributable 99mTc-ZHER2:41071 injections (concomitant medication)

Description

The safety attributable to 99mTc-ZHER2:41071 injections will be evaluated based on the rate of administration of concomitant medication (%)

Time Frame

24 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women with primary breast cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is > 18 years of age Diagnosis of primary breast cancer with possible lymph node metastases Availability of results from HER2 status previously determined on material from the primary tumor, either HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 2.0 cm in greatest diameter outside of the liver and kidneys 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 Subject is capable to undergo the diagnostic investigations to be performed in the study Informed consent Exclusion Criteria: 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) 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 Chernov, MD, Prof.

Organizational Affiliation

Tomsk NRMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

TomskNRMC

City

Tomsk

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

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