Breast Cancer Stage IIEarly Phase 1NCT05828238
Positron Emission Tomograph(PET) Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
A Early Phase 1 study testing [18F]SF-DEVD-2 and [18F]-FDG in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer Stage II, Breast Cancer Stage III, Solid Tumor
- What is being tested?
- [18F]SF-DEVD-2 and [18F]-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to Jan 2024
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily signed informed consent;
- Age18-70, male or female;
- Diagnosed with stage 2 or 3 breast cancer
- Solid tumors、masses larger than 2cm with lymph node metastasis
- Pathology is HER3+、triple negative patients
- Patients to be treated with neoadjuvant chemotherapy
Who cannot join
- Age greater than or equal to 70 years old
- Abnormal liver and kidney function (more than five times the normal value)
- Diagnosis level of breast cancer stage 4 or second time tumor patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Chunjing Yu, 15312238622, ycj_wxd1978@163.com
About this study
Official title: PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III, Solid Tumor
- Being tested
- [18F]SF-DEVD-2, [18F]-FDG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]SF-DEVD-2Drug
Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2
[18F]-FDGDrug
Patients will receive a tracer dose of 18F (5-10mCi) labelled FDG
| Study group | Role | What they receive |
|---|---|---|
| [18F]SF-DEVD-2 | Experimental | Not described Receives: Drug: [18F]SF-DEVD-2; Drug: [18F]-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of tissue distribution of [18F]-DEVD-2
Biodistribution of [18F] -DEVD-2 evaluated by the maximum standardized uptake value（SUVmax) in various organs during repeated [18F]-DEVD scans will be reported.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study startJan 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
- Investigators
- Chunjing Yu, Principal investigator, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828238
- Sponsor's protocol ID
- LS2023012
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 25 Apr 2023
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging Explores the Role of SF-DEVD-2 in Monitoring Tumor Efficacy
- ClinicalTrials.gov ID
- NCT05828238
- Acronym / sponsor ID
- LS2023012
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III, Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 25 Apr 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.
This is a single arm study to determining the value of apoptotic molecular probe SF-DEVD-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]SF-DEVD-2 | Experimental | Drug: [18F]SF-DEVD-2, Drug: [18F]-FDG |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients voluntarily signed informed consent;
- Age18-70, male or female;
- Diagnosed with stage 2 or 3 breast cancer
- Solid tumors、masses larger than 2cm with lymph node metastasis
- Pathology is HER3+、triple negative patients
Key exclusion criteria (3 listed)
- Age greater than or equal to 70 years old
- Abnormal liver and kidney function (more than five times the normal value)
- Diagnosis level of breast cancer stage 4 or second time tumor patients
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 |
|---|---|---|
| [18F]SF-DEVD-2Patients will receive a tracer dose of 18F (2-4mCi) labelled SF-DEVD-2 | Drug | [18F]SF-DEVD-2 |
| [18F]-FDGPatients will receive a tracer dose of 18F (5-10mCi) labelled FDG | Drug | [18F]SF-DEVD-2 |
Primary outcome
Evaluation of tissue distribution of [18F]-DEVD-2
Time frame: 7 days
Biodistribution of [18F] -DEVD-2 evaluated by the maximum standardized uptake value（SUVmax) in various organs during repeated [18F]-DEVD scans will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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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.
Chunjing Yu principal investigator
Affiliated Hospital of Jiangnan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]SF-DEVD-2 and [18F]-FDG in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Affiliated Hospital of Jiangnan 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 6 inclusion and 3 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 25 Apr 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chunjing Yu (15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tissue distribution of [18F]-DEVD-2 (time frame: 7 days). 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 25 Apr 2023.