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

Wuxi No. 4 People's Hospital

Status and phase: Unknown; Phase 1

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

Treatments: Drug: 18F-Al-NOTA-PRGD2 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02441972

LS2011051

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

18F-Al-NOTA-PRGD2 PET/CT

Experimental group

Description:

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

Treatment:

Drug: 18F-Al-NOTA-PRGD2 PET/CT