Radioactive tracer could reveal breast Cancer's HER2 status without a needle
NCT ID NCT04277338
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 trial tested a new radioactive tracer called 99mTc-HE3-G3 to see if it can safely and accurately detect HER2 protein in breast cancer tumors using SPECT imaging. Thirty adults with primary breast cancer received one injection of the tracer, followed by scans over 24 hours. The goal was to measure how the tracer spreads in the body and tumors, and to compare imaging results with standard biopsy tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Technetium-99m-labelled designed ankyrin repeat proteins HE3-G3 (99mTc-HE3-G3)
- What this could lead to
- If successful, this imaging method could help doctors see HER2 levels in breast cancer without needing a biopsy, guiding treatment decisions.
- What could go wrong
- This is an early Phase 1 trial with only 30 people. It focuses on safety and imaging, not treatment. The method may not be accurate enough for routine use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Oct 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 immunohistochemical test score of 3+ or FISH positive or 2. HER2-negative, defined as a immunohistochemical test 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 * 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
TomskNRMC
Tomsk, Russia
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Other studies related to the condition(s) this trial covers.
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