Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2017
Longer than P75 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 13, 2017
March 1, 2017
3.7 years
March 9, 2017
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day
Secondary Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
18F-Al-NOTA-MATBBN PET/CT
EXPERIMENTALImaging with 18F-Al-NOTA-MATBBN PET/CT
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 21233180RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chunjing Yu, PhD
Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 29, 2017
Study Start
April 20, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
April 13, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share