Breast TumorEarly Phase 1NCT03347864
68Ga-NOTA-RM26 PET/CT in Breast Tumor Patients
A Early Phase 1 study testing 68Ga-NOTA-RM26 in people with Breast Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Tumor
- What is being tested?
- 68Ga-NOTA-RM26
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2018
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form
Who cannot join
- The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jie Zang, MD, 15901495106@163.com
About this study
Official title: Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Breast Tumor Patients
This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Read the detailed description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.
- Conditions
- Breast Tumor
- Being tested
- 68Ga-NOTA-RM26
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-RM26Drug
1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-RM26 PET/CT | Experimental | The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min later Receives: Drug: 68Ga-NOTA-RM26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured.
Measured: 1 year
Secondary outcomes (1)
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD,PHD, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347864
- Sponsor's protocol ID
- PekingUMCH-NM15
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 20 Nov 2017
- 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 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Breast Tumor Patients
- ClinicalTrials.gov ID
- NCT03347864
- Acronym / sponsor ID
- PekingUMCH-NM15
- Conditions
- Breast Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Nov 2017 (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 an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed description
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-RM26 PET/CT | Experimental | Drug: 68Ga-NOTA-RM26The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min 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)
- patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form
Key exclusion criteria (1 listed)
- The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR 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 |
|---|---|---|
| 68Ga-NOTA-RM261.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans | Drug | 68Ga-NOTA-RM26 PET/CT |
Primary outcome
Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor
Time frame: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured.
1 secondary outcome
Adverse events collection
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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, MD,PHD study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
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 68Ga-NOTA-RM26 in people with Breast Tumor, 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 20 Nov 2017. 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 Jie Zang, MD (+86 10 69154196, 15901495106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor (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 20 Nov 2017.