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

Breast Neoplasms Clinical Trial

Official title:

Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03094897
• Other study ID #: Wuxi4PH
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: March 9, 2017
• Last updated: April 11, 2017
• Start date: April 20, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2017
• Source: Wuxi No. 4 People's Hospital
• Contact: chunjing Yu, PhD,MD
• Phone: 0510-88682783
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuxi No. 4 People's Hospital

References & 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 pep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.	1 week