Breast NeoplasmsEarly Phase 1NCT03094897
Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
A Early Phase 1 study testing 18F-Al-NOTA-MATBBN PET/CT and PET/CT in people with Breast Neoplasms and Prostatic Neoplasms, run by Wuxi No. 4 People's Hospital.
Trial summary
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Prostatic Neoplasms
- What is being tested?
- 18F-Al-NOTA-MATBBN PET/CT and PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2017to 31 Dec 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers or patients with age more than 18 yeas;
- The patients have been diagnosed with cancer or suspected with cancer;
- It must fulfill the ethical requirements and subjects have signed an informed consent.
Who cannot join
- Pregnancy or nursing mothers;
- Having drugs or alcohol dependence;
- Hypersensitive to the active or inactive ingredients of the study drug;
- Having attended other drug clinical trials within three months;
- Cardiac functional insufficiency;
- Hepatic and renal function insufficiency;
- Hypertensive patients with serious complications;
- Endangering the safety of life.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.
Read the detailed description
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
- Conditions
- Breast Neoplasms, Prostatic Neoplasms
- Being tested
- 18F-Al-NOTA-MATBBN PET/CT, PET/CT
- Keywords
- Breast Neoplasms,Prostatic Neoplasms
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Al-NOTA-MATBBN PET/CTDrug
18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
PET/CTDevice
Imaging with 18F-Al-NOTA-MATBBN PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Al-NOTA-MATBBN PET/CT | Experimental | Imaging with 18F-Al-NOTA-MATBBN PET/CT Receives: Drug: 18F-Al-NOTA-MATBBN PET/CT; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions will be measured.
Measured: 1 day
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 posted29 Mar 2017
- Study start20 Apr 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 4 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chunjing Yu, PhD, Principal investigator, Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094897
- Sponsor's protocol ID
- Wuxi4PH
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Honer M, Mu L, Stellfeld T, Graham K, Martic M, Fischer CR, Lehmann L, Schubiger PA, Ametamey SM, Dinkelborg L, Srinivasan A, Borkowski S. 18F-labeled bombesin analog for specific and effective targeting of prostate tumors expressing gastrin-releasing peptide receptors. J Nucl Med. 2011 Feb;52(2):270-8. doi: 10.2967/jnumed.110.081620. Epub 2011 Jan 13.
PubMed 21233180
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
- ClinicalTrials.gov ID
- NCT03094897
- Acronym / sponsor ID
- Wuxi4PH
- Conditions
- Breast Neoplasms, Prostatic Neoplasms
- Keywords
- Breast Neoplasms,Prostatic Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wuxi No. 4 People's HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 29 Mar 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.
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.
Detailed description
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Al-NOTA-MATBBN PET/CT | Experimental | Drug: 18F-Al-NOTA-MATBBN PET/CT, Device: PET/CTImaging with 18F-Al-NOTA-MATBBN PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteers or patients with age more than 18 yeas;
- The patients have been diagnosed with cancer or suspected with cancer;
- It must fulfill the ethical requirements and subjects have signed an informed consent.
Key exclusion criteria (8 listed)
- Pregnancy or nursing mothers;
- Having drugs or alcohol dependence;
- Hypersensitive to the active or inactive ingredients of the study drug;
- Having attended other drug clinical trials within three months;
- Cardiac functional insufficiency;
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-Al-NOTA-MATBBN PET/CT18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min. | Drug | 18F-Al-NOTA-MATBBN PET/CT |
| PET/CTImaging with 18F-Al-NOTA-MATBBN PET/CT. | Device | 18F-Al-NOTA-MATBBN PET/CT |
Primary outcome
Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
Time frame: 1 day
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions 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 13 Apr 2017.
- Results publication: PubMed 21233180Honer M, Mu L, Stellfeld T, Graham K, Martic M, Fischer CR, Lehmann L, Schubiger PA, Ametamey SM, Dinkelborg L, Srinivasan A, Borkowski S. 18F-labeled bombesin analog for specific and effective targeting of prostate tumors expressing gastrin-releasing peptide receptors. J Nucl Med. 2011 Feb;52(2):270-8. doi: 10.2967/jnumed.110.081620. Epub 2011 Jan 13.
- 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.
chunjing Yu, PhD principal investigator
Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-Al-NOTA-MATBBN PET/CT and PET/CT in people with Breast Neoplasms and Prostatic Neoplasms, run by Wuxi No. 4 People's Hospital.
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 3 inclusion and 8 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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, PhD,MD (0510-88682783, ycj_wxd1978@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 18F-Al-NOTA-MATBBN in malignant lesions (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094897, which also lists 1 linked publication.
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 13 Apr 2017.