New scan could spot breast cancer protein without needle
NCT ID NCT03991260
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study tested a new radioactive imaging agent called 99mTc-ADAPT6 to see if it can detect HER2 protein in breast cancer tumors using SPECT scans. Sixteen women with primary breast cancer received a single injection, followed by scans over six hours. The goal was to compare the imaging results with standard biopsy tests to see if the agent can accurately identify HER2 status.
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 ADAPT6
- What this could lead to
- If successful, this could provide a non-invasive way to determine HER2 status in breast cancer, potentially guiding treatment without needing a biopsy.
- What could go wrong
- This was a very small, early-phase study with only 16 participants, so results may not apply to all patients. The imaging agent may not accurately distinguish HER2-positive from HER2-negative tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
16 people
The number who actually took part.
- Started
-
Jun 2019
- Finished
-
Sep 2020
- Lead sponsor
-
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.
Who is studied
Patients with primary HER2-positive and HER2-negative breast cancer.
- Ages
-
18 to 80 years
- Sex
-
Female participants only
- Healthy volunteers
-
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 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
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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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