Breast CancerPhase 1/2NCT05622227
68Ga PET/CT Imaging in Breast Cancer Patients
A Phase 1/2 study testing Drug: 68Ga-P16-093 in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Drug: 68Ga-P16-093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to 31 Dec 2024
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients highly suggested by ultrasound or histologically confirmed;
- 68Ga-P16-093 PET/CT and 18F-FDG within two weeks;
- signed written consent.
Who cannot join
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Zhaohui Zhu, 86-13611093752, 13611093752@163.com
About this study
Official title: 68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
Read the detailed description
PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.
- Conditions
- Breast Cancer
- Being tested
- Drug: 68Ga-P16-093
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: 68Ga-P16-093Diagnostic test
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of breast cancer by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-P16-093 and 18F-FDG scan | Experimental | Within 1 week, each patient underwent 68Ga-P16-093 and 18F-FDG PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively. Receives: Diagnostic Test: Drug: 68Ga-P16-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
standardized uptake value (SUV) of tumor
comparing the SUVmax of tumor of different lesions derived from 68Ga-P16-093 AND 18F-FDG
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 posted18 Nov 2022
- Study start15 Nov 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622227
- Sponsor's protocol ID
- PekingUMCH-BCa093
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05622227
- Acronym / sponsor ID
- PekingUMCH-BCa093
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 2022 (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.
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
Detailed description
PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-P16-093 and 18F-FDG scan | Experimental | Diagnostic Test: Drug: 68Ga-P16-093Within 1 week, each patient underwent 68Ga-P16-093 and 18F-FDG PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- breast cancer patients highly suggested by ultrasound or histologically confirmed;
- 68Ga-P16-093 PET/CT and 18F-FDG within two weeks;
- signed written consent.
Key exclusion criteria (2 listed)
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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 |
|---|---|---|
| Drug: 68Ga-P16-093Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of breast cancer by PET/CT. | Diagnostic test | 68Ga-P16-093 and 18F-FDG scan |
Primary outcome
Diagnostic performance
Time frame: through study completion, an average of 1 year
comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
1 secondary outcome
standardized uptake value (SUV) of tumor
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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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.
Zhaohui Zhu 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 Phase 1/2 study testing Drug: 68Ga-P16-093 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 3 inclusion and 2 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 18 Nov 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xinyu Lu (86-18813128336, lslxysou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (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?
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 18 Nov 2022.