Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics

NCT ID: NCT02441972

Last Updated: 2017-03-10

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

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2020-12-31

Brief Summary

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The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.

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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Tumors Carcinoma, Bronchogenic Breast Carcinoma Cancer of Head and Neck Lymphoma, Malignant Soft Tissue Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-Al-NOTA-PRGD2 PET/CT

Imaging with 18F-Al-NOTA-PRGD2 PET/CT.

Group Type EXPERIMENTAL

18F-Al-NOTA-PRGD2 PET/CT

Intervention Type DRUG

18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.

Interventions

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18F-Al-NOTA-PRGD2 PET/CT

18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.

Intervention Type DRUG

Other Intervention Names

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18F-Alfatide II PET/CT

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

Maximum Eligible Age

85 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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Weixing Wan, Professor

Role: STUDY_CHAIR

Wuxi No. 4 People's Hospital

Locations

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Wuxi No. 4 People's Hospital

Wuxi, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunjing Yu, Dr.

Role: CONTACT

86-15312238622

Facility Contacts

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Chunjing Yu, M.D.

Role: primary

15312238622

References

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Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.

Reference Type RESULT
PMID: 16818691 (View on PubMed)

Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.

Reference Type RESULT
PMID: 18077538 (View on PubMed)

Wang L, Zhu X, Xue Y, Huang Z, Zou W, Zhang Z, Yu M, Pan D, Wang K. Ultrasensitive detection of uveal melanoma using [18F]AlF-NOTA-PRGD2 PET imaging. EJNMMI Res. 2024 Jul 5;14(1):62. doi: 10.1186/s13550-024-01123-4.

Reference Type DERIVED
PMID: 38967722 (View on PubMed)

Other Identifiers

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LS2011051

Identifier Type: -

Identifier Source: org_study_id

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