Breast Cancer99mTc-ADAPT6NCT03991260
99mTc-ADAPT6-based HER2 Imaging in Breast Cancer
An observational study of Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPECT
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- 5 Jun 2019to 5 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary HER2-positive and HER2-negative breast cancer.
Who may be able to join
- 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 > 1.0 cm in greatest diameter outside of the liver and kidneys
Show all 16Show fewer
- 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
- 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
- Subject is capable to undergo the diagnostic investigations to be performed in the study
- 11. Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- 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:
Read the 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:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
- 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.
- Conditions
- Breast Cancer
- Being tested
- SPECT
- Keywords
- 99mTc-ADAPT6, Breast Cancer, HER2 expression
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECTDiagnostic test
One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SPECT | |
| 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. Receives: Diagnostic Test: SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)
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
Measured: 6 hours
SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts)
99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts
Measured: 6 hours
SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)
Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts
Measured: 6 hours
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 (kcounts) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (kcounts)
Measured: 6 hours
Secondary outcomes (4)
Safety attributable to 99mTc-ADAPT6 injections (physical findings)
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)
Measured: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)
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)
Measured: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of adverse events (%)
Measured: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)
The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of administration of concomitant medication (%)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start5 Jun 2019
- Primary completion5 Jun 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- KTH Royal Institute of Technology, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Vladimir I Chernov, MD, Prof., Principal investigator, TomskNMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991260
- Sponsor's protocol ID
- ORI-1E
- Other IDs
- 99mTc-ADAPT6 [TomskNRMC]
- Acronym
- 99mTc-ADAPT6
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
- ClinicalTrials.gov ID
- NCT03991260
- Acronym / sponsor ID
- 99mTc-ADAPT6 / ORI-1E
- Conditions
- Breast Cancer
- Keywords
- 99mTc-ADAPT6, Breast Cancer, HER2 expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- KTH Royal Institute of Technology, Uppsala University
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.
The primary objective are:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- 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:
- To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
- To assess kinetics of 99mTc- ADAPT6 in blood;
- To evaluate dosimetry of 99mTc- ADAPT6;
- To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:
The secondary objective is:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The tested injected doses of 99mTc- ADAPT6 500 µg | – | Diagnostic Test: SPECTAt 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. |
| The tested injected doses of 99mTc- ADAPT6 1000 µg | – | Diagnostic Test: SPECTAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary HER2-positive and HER2-negative breast cancer.
Key inclusion criteria (16 listed)
- 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
- 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
- Hematological, liver and renal function test results within the following limits:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECTOne single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours. | Diagnostic test | The tested injected doses of 99mTc- ADAPT6 1000 µg, The tested injected doses of 99mTc- ADAPT6 500 µg |
Primary outcome
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
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
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
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)
4 secondary outcomes
Safety attributable to 99mTc-ADAPT6 injections (physical findings)
Time frame: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)
Time frame: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)
Time frame: 24 hours
Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I Chernov, MD, Prof. principal investigator
TomskNMRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%) (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.