99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Fujian Medical University
• Treatments: HYNIC-3PRGD(2)

Criteria

Inclusion Criteria:

• Males and females, ≥30 years old

• Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer.

• The lung cancer will be histologically confirmed or results of histology will be available.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential

• Known severe allergy or hypersensitivity to IV radiographic contrast.

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.