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Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer

This study is comparing two different imaging techniques for lung cancer. Researchers want to see if a new scan, called 99mTC-EC-DG SPECT/CT, provides images of lung tumors and any spread of cancer that are similar to the standard 18F-FDG PET/CT scans. You may be able to join if you are at least 18 years old and have a confirmed diagnosis of lung cancer. The main goal is to show that the new 99mTC-EC-DG SPECT/CT scan is just as good as the current PET/CT scan for finding lung cancer and its spread. The study is currently unclear on its recruitment status and plans to enroll 154 participants.

Study design
This is an interventional study comparing two imaging techniques in patients with lung cancer. It aims to enroll 154 participants.
What's involved
You would need to have a tissue diagnosis of your primary lung lesion, a SPECT/CT procedure, a baseline DCCT scan, and a whole-body bone scan. Images will be compared approximately every 4 to 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Images will be compared at the core image lab at approximately every 4 to 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01394679

A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer

Not Yet Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Cell>Point LLC
~154 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:(99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)18 F FDG followed by PET/CT imaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions
Measured over Images will be compared at the core image lab at approximately every 4 to 6 weeks

Conditions

Lung Cancer

Explore related trials

Lung Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Cynthia Phurrough, BS · STUDY_DIRECTOR · Consultanat

Who to contact

Greg Colip, JD
[email protected]
281-288-4643
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 consistent with a diagnosis of lung cancer. Cytology results confirming lung cancer from a bronchoscope procedure will also be acceptable. A copy of the actual report (biopsy/cytology or CT scan) must be requested by the patient through a medical release form if not already done. The copy must be available to the study doctor within 15 days of the PET imaging study. 4. The patient will not be receiving treatment for lung cancer (surgery, radiation, and/or chemotherapy), or, if the patient has had lung cancer in the past, all previous therapy was completed at least 3 months prior to being enrolled in the study. 5. If a tissue diagnosis of the primary lesion was not done prior to enrollment, the patient must agree to have a tissue diagnosis of the primary lesion within 15 days of the PET/CT study but prior to initiation of therapy, independent of the PET/CT results. 6. The patient must be referred for a PET/CT scan on the basis of clinical and radiological (CT) evidence for a diagnosis of lung cancer. 7. The patient will have an Eastern Co-operative Oncology Group (ECOG) performance rating \< or = 2. 8. The patients will be males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study. Postmenopausal is defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). 9. Females of childbearing potential and males with female sexual partners of childbearing potential must agree to use one of the following acceptable birth control methods:

What this trial measures

  • Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesionsImages will be compared at the core image lab at approximately every 4 to 6 weeks

    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.