Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics

April 11, 2017 updated by: Wuxi No. 4 People's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Volunteers or patients with age more than 18 yeas;
  2. The patients have been diagnosed with cancer or suspected with cancer;
  3. It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

  1. Pregnancy or nursing mothers;
  2. Having drugs or alcohol dependence;
  3. Hypersensitive to the active or inactive ingredients of the study drug;
  4. Having attended other drug clinical trials within three months;
  5. Cardiac functional insufficiency;
  6. Hepatic and renal function insufficiency;
  7. Hypertensive patients with serious complications;
  8. Endangering the safety of life.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-Al-NOTA-MATBBN PET/CT
Imaging with 18F-Al-NOTA-MATBBN PET/CT
Drug: 18F-Al-NOTA-MATBBN PET/CT
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.
Device: PET/CT
Imaging with 18F-Al-NOTA-MATBBN PET/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events collection
Time Frame: 1 week
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuxi No. 4 People's Hospital

Investigators

  • Principal Investigator: chunjing Yu, PhD, Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 9, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wuxi4PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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