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About
This is a multi-center Phase 1 b study designed to expand the patient safety using 99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.
Full description
Male and female patients at least 18 years old with untreated Non-small Cell Lung Cancer who have non-incisional biopsy definitive evidence of disease (or cytology results from a bronchoscope procedure confirming NSCLC) and who have been previously certified (per Centers for Medicare and Medicaid Services requirements)by their physicians will be consented for the study. The study consists of a screening visit, gold-standard 18F-FDG PET/CT imaging followed by the investigational agent 99mTc-EC-DG with SPECT/CT(if the PET/CT was performed as part of the pre-study activities on a qualified PET camera for this study, the SPECT/CT must be done within 45 days of the PET/CT imaging procedures). The study procedures can be performed within 5-7 days of signing the informed consent. During the 99mTc-EC-DG SPECT/CT visit of the study, pharmacokinetic (PK) blood draws and urine collection will be taken and radiation dosimetry (Planar Imaging) will be performed at specified time points post 99mTc-EC-DG injection. Patients will be seen 24 hours after the 99mTc-EC-DG injection for safety and final PK blood and urine collection. A 21-day follow-up period (after the SPECT/CT image) will allow the investigator to acquire additional imaging, surgical, pathology and treatment documentation (an actual patient visit is not required at the 21 day follow-up time point).
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Male or female patients at least 18 years old;
Have non-incisional biopsy demonstrating definitive evidence for NSCLC and have not been treated for lung cancer (surgery, radiation and/or chemotherapy). A copy of the actual report 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 28 days of the screening visit/ Visit 1 ;
Be certified as per Centers for Medicare and Medicaid Services (CMS) requirements and be eligible for a PET scan;
Have an Eastern Co-operative Oncology Group (ECOG) performance rating ≤ 2 (see Appendix 1);
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);
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:
Have a fasting blood glucose of less than 200 mg/dL at screening;
Have reported clinical symptoms consistent with a confirmed diagnosis of NSCLC;
Be able to tolerate SPECT/CT and PET/CT imaging. This includes:
Laying in the same position without moving for approximately 45 minutes;
Able to tolerate a claustrophobic area;
Ability to hold their arms overhead for approximately 45 minutes;
Be able to fast prior to SPECT/CT and PET/CT imaging, with length of fasting dependent on the time of the scan:
Be able to eat a high protein/low carbohydrate meal as the last meal before SPECT/CT and PET/CT imaging (or as per the site's fasting/diet restrictions);
Be able to make the scheduled appointments within the designated time windows [PET/CT imaging within 7 days of qualifying for the study, the second imaging session with SPECT/CT imaging 1 - 3 days after the initial imaging visit, with at least 24 hours between PET/CT and SPECT/CT imaging (if the PET/CT is performed as part of pre-study activities on a qualified PET camera for this study, the SPECT/CT must be done within 45 days of the PET/CT imaging procedure)];
Have safety laboratory values that in the opinion of the Investigator do not place the patient at undue risk if the patient were to participate in the study. This includes (but is not limited to):
Able to understand and provide signed informed consent;
Females of childbearing potential must have a negative urine or serum β-human chorionic gonadotropin (hCG) pregnancy test at screening.
Exclusion Criteria
Primary purpose
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4 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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