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

Early Phase 1

• Conditions: Breast Neoplasms; Prostatic Neoplasms
• Interventions: Drug: 18F-Al-NOTA-MATBBN PET/CT; Device: PET/CT

• Registration Number: NCT03094897
• Lead Sponsor: Wuxi No. 4 People's Hospital

Brief Summary

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 Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13
• Study Start: 2017-04-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Al-NOTA-MATBBN PET/CT	18F-Al-NOTA-MATBBN PET/CT	Imaging with 18F-Al-NOTA-MATBBN PET/CT
18F-Al-NOTA-MATBBN PET/CT	PET/CT	Imaging with 18F-Al-NOTA-MATBBN PET/CT

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.