Breast CancerNCT04758416
Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- biopsy or surgical pathology in metastases and 68Ga-HER2 affibody,18F-FDG, 18F-FES
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 31 Dec 2022
- Phase
- Observational
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 metastatic breast cancer patients
Who may be able to join
- Subjects voluntarily joined the study, signed informed consent, and had good compliance.
- Female patients aged over 18 years (including cutoff value).
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.
Who cannot join
- Pregnancy or lactation.
- Alcohol allergy is not suitable for FES-PET/ C.
- There are contraindications for patients who are expected to have metastasis puncture or surgery.
- Mental disorders or other conditions affecting patient compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Cancer Center Institutional Review Board
Shanghai, Shanghai Municipality
Xichun Hu, MD, PhD, 64175590 ext. 5006, huxicun@gmail.com
About this study
Official title: A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
Read the detailed description
A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
- Conditions
- Breast Cancer
- Being tested
- biopsy or surgical pathology in metastases, 68Ga-HER2 affibody,18F-FDG, 18F-FES
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy or surgical pathology in metastasesProcedure or surgery
biopsy or surgical pathology in extrahepatic/liver/brain metastases
68Ga-HER2 affibody,18F-FDG, 18F-FESDrug
68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancer patients | 50 metastatic breast cancer patients Receives: Procedure: biopsy or surgical pathology in metastases; Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the subtype value of dual-PET in extrahepatic metastases
Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
Measured: 2 year
Secondary outcomes (3)
Verify the HER2-PET value in liver metastasis
Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in liver metastasis.
Measured: 2 year
Verify the HER2-PET value in brain metastasis
Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis.
Measured: 2 year
Heterogeneity in metastatic lesions
Observe the heterogeneity of ER and HER2 expression in metastatic lesions.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start31 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 Fudan UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xichun Hu, Fudan University
- Investigators
- Xichun Hu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758416
- Sponsor's protocol ID
- STANDPOINT
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
- ClinicalTrials.gov ID
- NCT04758416
- Acronym / sponsor ID
- STANDPOINT
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Feb 2021 (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.
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
Detailed description
A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancer patients | – | Procedure: biopsy or surgical pathology in metastases, Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES50 metastatic breast cancer patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 metastatic breast cancer patients
Key inclusion criteria (4 listed)
- Subjects voluntarily joined the study, signed informed consent, and had good compliance.
- Female patients aged over 18 years (including cutoff value).
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.
Key exclusion criteria (4 listed)
- Pregnancy or lactation.
- Alcohol allergy is not suitable for FES-PET/ C.
- There are contraindications for patients who are expected to have metastasis puncture or surgery.
- Mental disorders or other conditions affecting patient 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 |
|---|---|---|
| biopsy or surgical pathology in metastasesbiopsy or surgical pathology in extrahepatic/liver/brain metastases | Procedure or surgery | Metastatic breast cancer patients |
| 68Ga-HER2 affibody,18F-FDG, 18F-FES68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical. | Drug | Metastatic breast cancer patients |
Primary outcome
Verify the subtype value of dual-PET in extrahepatic metastases
Time frame: 2 year
Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
3 secondary outcomes
Verify the HER2-PET value in liver metastasis
Time frame: 2 year
Verify the HER2-PET value in brain metastasis
Time frame: 2 year
Heterogeneity in metastatic lesions
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Xichun Hu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fudan University 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 4 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 20 Apr 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.
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 Xichun Hu, MD, PhD (64175590 ext. 5006, huxicun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the subtype value of dual-PET in extrahepatic metastases (time frame: 2 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 20 Apr 2022.