A Multicenter Phase 3 Study Comparing the Diagnostic Accuracy of 99mTc EC DG SPECT/CT Versus 18F FDG PET/CT for Diagnosing and Staging Patients Who Have Clinical and Radiological (CT) Evidence Consistent With a Diagnosis of Lung Cancer
Cell>Point LLC
Summary
The purpose of this study is to determine if the images of the primary lesions of lung cancer and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the same as the PET/CT 18F-FDG scans.
Description
1. To demonstrate that SPECT/CT (99mTc EC DG) is not inferior to PET/CT (18F FDG PET/CT) for sensitivity or specificity measures when image interpretation of primary and metastatic lesions are compared against a truth standard in patients with a high likelihood of lung cancer. 2. To expand the patient safety experience using 99mTc EC DG.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The subject is a male or female patient at least 18 years old. 2. The subject must agree at the time of enrollment to have the following procedures: * A tissue diagnosis of the primary lesion either prior to enrollment or within 15 days of the PET/CT study but before initiation of therapy * A SPECT/CT procedure * A baseline DCCT scan * A whole-body bone scan * A follow-up focused DCCT scan (if indicated) 3. The patient has had a non incisional biopsy demonstrating definitive evidence for lung cancer OR have clinical evidence and CT scan results consisten…
Interventions
- Drug(99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)
One injection of Technetium-99m Ethylenedicysteine-Deoxyglucose to yield a target dose of 25 mCi (range of 20-30 mCi)by IV push and less than 1 mg of EC-DG
- Drug18 F FDG followed by PET/CT imaging
Single injection of 18 F FDG range of 10-20 mCi
Location
- Decatur Memorial HospitalDecatur, Illinois