Prostate CancerEarly Phase 1NCT02747290
68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
A Early Phase 1 study testing 68Ga-NOTA-BBN-RGD in people with Prostate Cancer, 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-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-NOTA-BBN-RGD
- 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
- Jul 2014to Jul 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.
Who cannot join
- The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jingjing Zhang, MD., +86 10 69155513, zhangjingjingtag@163.com
About this study
Official title: Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer 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-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Read the detailed description
Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-NOTA-BBN-RGD
- Keywords
- BBN-RGD, PET, integrin αvβ3, GRPR
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-BBN-RGDDrug
68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NOTA-BBN-RGD PET/CT | Experimental | The patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later. Receives: Drug: 68Ga-NOTA-BBN-RGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in prostate cancer 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 posted21 Apr 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- 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
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Fang Li, MD., Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747290
- Sponsor's protocol ID
- PUMCHNM011
- Other IDs
- ZIAEB000073
- Status last verified
- Mar 2016
- First submitted
- 19 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02747290
- Acronym / sponsor ID
- PUMCHNM011
- Conditions
- Prostate Cancer
- Keywords
- BBN-RGD, PET, integrin αvβ3, GRPR
- 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
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- 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-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed description
Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.
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-BBN-RGD PET/CT | Experimental | Drug: 68Ga-NOTA-BBN-RGDThe patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.
Key exclusion criteria (1 listed)
- The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
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-BBN-RGD68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans | Drug | 68Ga-NOTA-BBN-RGD PET/CT |
Primary outcome
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
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 prostate cancer 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 21 Apr 2016.
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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.
Fang Li, MD. 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-BBN-RGD in people with Prostate 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 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 21 Apr 2016. 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 Zhaohui Zhu, MD.PhD. (+86 10 69154196, 13611093752@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-BBN-RGD in prostate cancer (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 21 Apr 2016.