Breast CancerNCT06104085
99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer
A study testing 99mTc-MY6349 SPECT/CT scan in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer… 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?
- 99mTc-MY6349 SPECT/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Female, aged between 18 and 80 years old.
- Patients with suspected or definite diagnosis of triple-negative breast cancer.
- Patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer.
- Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period.
Who cannot join
- Suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases.
- Claustrophobia.
- In the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50mSv.
- Pregnant or lactating women.
- Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month.
- There is any situation in which the conductor of this study believes that any aspect related to this experiment may cause harm or be potentially harmful.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Li Huo, 86-13910801986, huoli@pumch.cn
About this study
Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.
- Conditions
- Breast Cancer
- Being tested
- 99mTc-MY6349 SPECT/CT scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-MY6349 SPECT/CT scanDiagnostic test
Triple-negative breast cancer patients underwent 99mTc-MY6349 SPECT/CT imaging to observe the binding ability of this tracer to Trop2 in the tumor and the uptake of the drug by the tumor, combined with the pathological expression level of Trop2 in the patient's lesions and 18F-FDG PET/CT imaging uptake to evaluate the efficacy of 99mTc-MY6349 in the diagnosis of triple-negative breast cancer; at the same time, combined with the treatment effect of patients using the anti-Trop2 targeted antibody gosatuzumab, the analysis of 99mTc-MY6349 SPECT/CT imaging prediction of prognosis in patients with triple-negative breast cancer treated with gosatuzumab.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-MY6349 SPECT/CT | Experimental | Inject 99mTc-MY6349 and then perform SPECT/CT scan. Receives: Diagnostic Test: 99mTc-MY6349 SPECT/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
semi-quantitative analysis
use the region of interest (ROI) method to measure the ratio of uptake at the lesion site to liver uptake
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start13 Sep 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104085
- Sponsor's protocol ID
- K4429
- Status last verified
- Oct 2023
- First submitted
- 3 Sep 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Y, Hao Z, Gao H, Yang G, Pan B, Zhu M, Wan Y, Shi J, Huo L, Chen H, Wang F. [99mTc]Tc-MY6349 Probe for Trop2-Targeted SPECT Imaging: From Preclinical to Pilot Clinical Study. J Nucl Med. 2025 Apr 1;66(4):543-551. doi: 10.2967/jnumed.124.268564.
PubMed 39947911
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06104085
- Acronym / sponsor ID
- K4429
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2023 (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.
Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-MY6349 SPECT/CT | Experimental | Diagnostic Test: 99mTc-MY6349 SPECT/CT scanInject 99mTc-MY6349 and then perform SPECT/CT scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, aged between 18 and 80 years old.
- Patients with suspected or definite diagnosis of triple-negative breast cancer.
- Patients with suspected or confirmed triple-negative recurrent or metastatic breast cancer.
- Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, isolation contraceptive measures must be taken during this study period.
Key exclusion criteria (6 listed)
- Suffering from severe gastrointestinal, cardiovascular, liver, kidney, blood system, endocrine, respiratory system, immune deficiency and other serious diseases.
- Claustrophobia.
- In the past year, due to other clinical medical treatment or scientific research needs, received ionizing radiation outside the scope of this experiment, so that the annual radiation exposure dose exceeded 50mSv.
- Pregnant or lactating women.
- Received experimental drug or device treatment (with unclear efficacy or safety) within 1 month.
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 |
|---|---|---|
| 99mTc-MY6349 SPECT/CT scanTriple-negative breast cancer patients underwent 99mTc-MY6349 SPECT/CT imaging to observe the binding ability of this tracer to Trop2 in the tumor and the uptake of the drug by the tumor, combined with the pathological expression level of Trop2 in the patient's lesions and 18F-FDG PET/CT imaging uptake to evaluate the efficacy of 99mTc-MY6349 in the diagnosis of triple-negative breast cancer; at the same time, combined with the treatment effect of patients using the anti-Trop2 targeted antibody gosatuzumab, the analysis of 99mTc-MY6349 SPECT/CT imaging prediction of prognosis in patients with triple-negative breast cancer treated with gosatuzumab. | Diagnostic test | 99mTc-MY6349 SPECT/CT |
Primary outcome
semi-quantitative analysis
Time frame: through study completion, an average of 1 year
use the region of interest (ROI) method to measure the ratio of uptake at the lesion site to liver uptake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Derived from this study: PubMed 39947911Sun Y, Hao Z, Gao H, Yang G, Pan B, Zhu M, Wan Y, Shi J, Huo L, Chen H, Wang F. [99mTc]Tc-MY6349 Probe for Trop2-Targeted SPECT Imaging: From Preclinical to Pilot Clinical Study. J Nucl Med. 2025 Apr 1;66(4):543-551. doi: 10.2967/jnumed.124.268564.
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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.
Li Huo principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-MY6349 SPECT/CT scan in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Oct 2023. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (86-13910801986, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semi-quantitative analysis (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06104085, which also lists 1 linked publication.
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 27 Oct 2023.