Breast CancerNCT06194565
99mTc-ABH2 SPECT/CT in Breast Cancer
A study testing 99mTc-ABH2 in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast 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-ABH2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 30 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form
Who cannot join
- pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
Trial locations and contacts
1 site in 1 country.
Hongli MD Jing contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hongli Jing, annsmile1976@sina.com
About this study
Official title: Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.
Read the detailed description
This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.
- Conditions
- Breast Cancer
- Being tested
- 99mTc-ABH2
- 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-ABH2Drug
Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-ABH2 SPECT/CT | Experimental | The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later. Receives: Drug: 99mTc-ABH2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongli MD Jing, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194565
- Sponsor's protocol ID
- PUMCH-ABH2
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
- ClinicalTrials.gov ID
- NCT06194565
- Acronym / sponsor ID
- PUMCH-ABH2
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.
Detailed description
This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-ABH2 SPECT/CT | Experimental | Drug: 99mTc-ABH2The patients will be injected with 5.55 to 7.4 MBq per kilogram body weight of 99mTc-ABH2 in one dose intravenously and undergo SPECT/CT scan 1h to 2h later. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form
Key exclusion criteria (1 listed)
- pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding
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-ABH2Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time. | Drug | 99mTc-ABH2 SPECT/CT |
Primary outcome
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
Time frame: 1 year
Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
Hongli MD Jing contact
Hongli MD Jing 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-ABH2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuwei Zhang (+8618511071577, ywzhangwork@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions (time frame: 1 year). 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 8 Jan 2024.