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

NCT ID: NCT03094897

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Breast Neoplasms Prostatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Open Label

Study Groups

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18F-Al-NOTA-MATBBN PET/CT

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

Group Type EXPERIMENTAL

18F-Al-NOTA-MATBBN PET/CT

Intervention Type DRUG

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.

PET/CT

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DRUG

PET/CT

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuxi No. 4 People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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chunjing Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)

Central Contacts

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chunjing Yu, PhD,MD

Role: CONTACT

0510-88682783

min Yang, PhD

Role: CONTACT

0510-88682783

References

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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.

Reference Type RESULT
PMID: 21233180 (View on PubMed)

Other Identifiers

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Wuxi4PH

Identifier Type: -

Identifier Source: org_study_id

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