Not Yet RecruitingPhase 3

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

United States154 participantsStarted 2025-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The subject is a male or female patient at least 18 years old.
✓. The subject must agree at the time of enrollment to have the following procedures:
✓. 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.
✓. 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.
✓. 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.
✓. 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.
✓. The patient will have an Eastern Co-operative Oncology Group (ECOG) performance rating \< or = 2.
✓. 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).

Exclusion criteria

✕. Any clinically significant safety concerns (laboratory, EKG, physical examination, other) that, in the opinion of the Investigator, would place the patient at undue risk if the patient were to participate in the study.
✕. The patient is undergoing any current treatment for cancer (radiation therapy, surgery, or chemotherapy).
✕. The patient is diabetic with insulin dependence. (Patients who have known insulin dependence for diabetes can be included in the study if the standard of care protocol in place at the clinical site provides for the management of the patient's glucose level sufficiently to allow the PET/CT imaging to be performed. The same glucose management used for the PET/CT imaging should be applied to the SPECT/CT imaging procedures. A waiver will be required to be completed by the clinical site and approved by the sponsor or designee.)
✕. The patient's weight is above the SPECT/CT and PET/CT table weight limit.
✕. The patient has a known hypersensitivity to EC DG or FDG or similar compounds including any of the inactive ingredients.
✕. The patient has a known or suspected pregnancy, lactation or planned pregnancy (females and male partners).
✕. The patient has clinically significant mental illness (to be determined by the Investigator).
✕. The patient has exposure to any investigational agent within 30 days prior to the screening visit or is participating in an ongoing clinical study. (This criterion can be overruled by the Principal Investigator with appropriate documentation of the reason for the exception.)

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

Timeframe: Images will be compared at the core image lab at approximately every 4 to 6 weeks

Trial details

NCT IDNCT01394679

SponsorCell>Point LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Greg Colip, JD

281-288-4643 gcolip@sbcglobal.net

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