Can a radioactive tracer pinpoint Cancer's first stop?
NCT ID NCT07764653
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing whether a radioactive tracer, technetium Tc 99m sulfur colloid, can accurately locate sentinel lymph nodes in women with early-stage breast cancer. The sentinel node is the first lymph node cancer is likely to spread to, and finding it helps guide surgery. The study compares this tracer to a standard blue dye to see which is better at detecting these nodes, and also checks for safety and consistency between the two methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Technetium Tc 99m Sulfur Colloid Injection (a radioactive tracer)
- What this could lead to
- If successful, this could offer a more accurate and safer way to locate sentinel lymph nodes during breast cancer surgery, potentially reducing the need for more invasive lymph node removal.
- What could go wrong
- This is a phase 3 trial, but results are not yet available. The tracer may not be as effective as the standard dye in all patients, and there is a small risk of radiation exposure or allergic reactions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
213 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
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Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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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. Able to understand and voluntarily sign a written informed consent. 2. Female subjects aged 18-70 years ( including 18 and 70 years ). 3. Histologically confirmed diagnosis of invasive breast cancer or primary invasive breast cancer or ductal carcinoma in situ (DCIS) ; 4. Clinical stage 1 or 2; 5. For subjects undergoing surgical treatment, axillary sentinel lymph node biopsy is part of the surgical plan; 6. The axillary lymph nodes were negative by imaging examination or confirmed by fine needle aspiration. 7. Conventional preoperative examination showed no clear surgical contraindications Exclusion criteria 1)Participants are allergic to the test drug or its excipients or have a history of severe drug allergy ; 2)Participants with prior surgery for breast cancer or neoadjuvant chemotherapy ; 3)inflammatory breast cancer ; 4)Ipsilateral axillary clinical examination or imaging examination positive or puncture lymph node pathology positive, no breast cancer histopathological diagnosis or no puncture pathological examination ; 5)Have received any form of breast augmentation surgery ; 6)Participants with liver or kidney dysfunction, ALT, AST\>2.5 times ULN, Bilirubin \>1.5 times ULN, Serum creatinine \>1.5 times, or Investigators believe that liver and / or kidney damage to the extent that patients should not participate in this study;; 7)With serious or uncontrollable diseases : such as severe cardiovascular and cerebrovascular diseases ( blood disease, chronic congestive heart failure NYHA classification ≥ III level, etc. ), severe pulmonary insufficiency ( one second rate FEV1 / FVC \< 50 % or FEV1 \< 50 % predicted value or maximum ventilation volume per minute MVV \< 50L / min ), psychiatric patients ; 8)Participants with active infection of infectious diseases screening ( hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody ) ; 9)participated in clinical trials of other drugs within 3 months before screening; 10)) Patients with positive pregnancy test or pregnancy plan during lactation or screening period to 3 months after administration and unwilling to take effective contraceptive measures or egg donation plan; 11)Investigators considered that it was not suitable for the patients to participate in this trial
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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
-
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
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Other studies related to the condition(s) this trial covers.
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