Breast CancerEarly Phase 1NCT04289532
Integrin α6-targeted SPECT Imaging of Breast Cancer
A Early Phase 1 study testing 99mTc-RWY in people with Breast Cancer, run by Peking University at 1 site in China.
Trial summary
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 99mTc-RWY
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2018to 30 Jun 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers.
- Body mass index (BMI) at 19 to 25 [Body mass index = body weight (kg)/ height squared (m2)];
- Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;
- Informed written consents were obtained from all 9 subjects before the procedure.
- Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.
- Exclution Criteria:
- The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Health Science Center
Beijing, Beijing Municipality
About this study
Official title: First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.
Read the detailed description
Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.
- Conditions
- Breast Cancer
- Being tested
- 99mTc-RWY
- Keywords
- Breast cancer, integrin α6, SPECT
- 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-RWYDrug
Also called 99mTc-labeled peptide targeting integrin α6
99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-RWY SPECT/CT | Experimental | Volunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later. Receives: Drug: 99mTc-RWY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Clearance
The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.
Measured: 1,3,5,10,15,30,60,120 minutes post-injection
Excretion
The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.
Measured: 0-24 hours post-injection
Biodistribution
Area under the activity-time curve from hour 0 to last measurable activity.
Measured: 0.5,1,2,4,24 hours post-injection
SPECT/CT imaging
Image brightness is observed。
Measured: post-injection
Distributed in organs
The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.
Measured: 0.5,1,2,4,24 hours post-injection
Secondary outcomes (1)
Incidence of adverse events
Adverse events within 1 week after the injection and scanning were followed and assessed.
Measured: 1 week post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start8 Mar 2018
- Primary completion1 Jun 2019
- Study completion30 Jun 2019
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 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Union Hospital, Jilin University, Sun Yat-sen University
- Responsible party
- Principal investigator, Fan Wang, Beijing University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289532
- Sponsor's protocol ID
- 010006
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer
- ClinicalTrials.gov ID
- NCT04289532
- Acronym / sponsor ID
- 010006
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, integrin α6, SPECT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- China-Japan Union Hospital, Jilin University, Sun Yat-sen University
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Feb 2020 (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.
A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.
Detailed description
Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-RWY SPECT/CT | Experimental | Drug: 99mTc-RWYVolunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers.
- Body mass index (BMI) at 19 to 25 [Body mass index = body weight (kg)/ height squared (m2)];
- Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;
- Informed written consents were obtained from all 9 subjects before the procedure.
- Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.
Key exclusion criteria (0 listed)
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-RWYAlso: 99mTc-labeled peptide targeting integrin α699mTc-RWY were injected into volunteers and patients before the SPECT/CT scans . | Drug | 99mTc-RWY SPECT/CT |
Primary outcome
Blood Clearance
Time frame: 1,3,5,10,15,30,60,120 minutes post-injection
The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.
Excretion
Time frame: 0-24 hours post-injection
The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.
Biodistribution
Time frame: 0.5,1,2,4,24 hours post-injection
Area under the activity-time curve from hour 0 to last measurable activity.
SPECT/CT imaging
Time frame: post-injection
Image brightness is observed。
Distributed in organs
Time frame: 0.5,1,2,4,24 hours post-injection
The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.
1 secondary outcome
Incidence of adverse events
Time frame: 1 week post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 99mTc-RWY in people with Breast Cancer, run by Peking 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 7 inclusion and 0 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: finished, as of the sponsor's last update on 6 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Clearance (time frame: 1,3,5,10,15,30,60,120 minutes post-injection). The study lists 5 primary outcomes in all. 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 6 Mar 2020.