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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03094897
Enrollment
30
Registered
2017-03-29
Start date
2017-04-20
Completion date
2020-12-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Prostatic Neoplasms

Keywords

Breast Neoplasms,Prostatic Neoplasms

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.

Interventions

DRUG18F-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.

DEVICEPET/CT

Imaging with 18F-Al-NOTA-MATBBN PET/CT.

Sponsors

Wuxi No. 4 People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Open Label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions1 dayThe 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

MeasureTime frameDescription
Adverse events collection1 weekAdverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.

Contacts

Primary Contactchunjing Yu, PhD,MD
ycj_wxd1978@163.com0510-88682783
Backup Contactmin Yang, PhD
ymzfk@163.com0510-88682783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026