A Multi-Center Phase 1b Pharmacokinetic and Radiation Dosimetry Study Evaluating 99mTc-EC-DG SPECT/CT in Patients With Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Cell>Point LLC
- Enrollment
- 4
- Locations
- 3
- Primary Endpoint
- Safety: through adverse event collection
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed 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).
Investigators
Eligibility 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:
- •Surgically sterile (hysterectomy or bilateral oophorectomy);
- •Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Documentation is required;
- •Intrauterine device (IUD) in place for at least 3 months;
- •Double-barrier method (condom and diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety: through adverse event collection
Time Frame: from 99mTc-EC-DG injection through 21 days
Secondary Outcomes
- Pharmacokinetic (blood)(0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours)
- Pharmacokinetic (urine)(pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection)
- Comparison of the results of EC-DG:SPECT/CT (als) to biopsy results and FDG:PET/CT (als)(At end of study)
- Radiation Dosimetry (whole body planar imaging)(15 minutes, 2, 4, 6 hours post injection)