99mTc-ADAPT6-based HER2 Imaging in Breast Cancer (99mTc-ADAPT6)

March 30, 2021 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6

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:

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with primary HER2-positive and HER2-negative breast cancer.

Description

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Diagnosis of primary breast cancer with possible lymph node metastases

  3. 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
  4. Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion > 1.0 cm in greatest diameter outside of the liver and kidneys

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

    • White blood cell count: > 2.0 x 10^9/L
    • Haemoglobin: > 80 g/L
    • Platelets: > 50.0 x 10^9/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 (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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

11. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The tested injected doses of 99mTc- ADAPT6 500 µg
At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 500 µg. Subjects withdrawn from the study for any reason will be replaced.
Diagnostic test: SPECT
One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.
The tested injected doses of 99mTc- ADAPT6 1000 µg
At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 1000 µg. Subjects withdrawn from the study for any reason will be replaced.
Diagnostic test: SPECT
One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)
Time Frame: 6 hours
Whole-body 99mTc-ADAPT6 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
6 hours
SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts)
Time Frame: 6 hours
99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts
6 hours
SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
Time Frame: 6 hours
Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts
6 hours
Tumor-to-background ratio (SPECT)
Time Frame: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (kcounts)
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety attributable to 99mTc-ADAPT6 injections (physical findings)
Time Frame: 24 hours
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (% of cases with abnormal findings relative to baseline)
24 hours
Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)
Time Frame: 24 hours
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)
24 hours
Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)
Time Frame: 24 hours
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of adverse events (%)
24 hours
Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)
Time Frame: 24 hours
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of administration of concomitant medication (%)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University
KTH Royal Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vladimir I Chernov, MD, Prof., TomskNMRC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 99mTc-ADAPT6
  • 99mTc-ADAPT6 [TomskNRMC] (OTHER: TomskNRMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on SPECT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings