Phase 2 Study Comparing 99mTc-EC-DG SPECT/CT With 18F FDG PET/CT in Patients With Non-small Cell Lung Cancer (NSCLC)
A Multicenter Phase 2 Study Comparing 99m Tc EC-DG SPECT/CT With 18F FDG PET/CT in the Evaluation of Patients With Non-small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
22
2 countries
6
Brief Summary
This is a multiple-center Phase 2 study designed to expand the patient safety and clinical information using 99m Tc-Ec-DG with Spect/CT imaging, to develop procedures and methods for evaluation of the imaging studies, to determine comparability of diagnostic information between SPECT and SPECT/CT imaging and to to compare the safety and efficacy of 99m Tc-EC-DG SPECT/CT with 18F-FDG PET/CT in imaging patients with biopsy confirmed diagnosis of Non-small Cell Lung Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 19, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 22, 2013
March 1, 2013
1.1 years
March 18, 2009
March 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: Through adverse event collection
from 99m Tc-Ec-DG injection through 21 days
Secondary Outcomes (3)
Efficacy: Comparison of 18F FDG PET/CT image against 99m Tc-EC-DG image
End of study
Efficacy: determine comparability of diagnostic information between SPECT (acs) and SPECT/CT (als) imaging
End of Study
Efficacy: To provide evidence of 99m Tc-Ec-DG in identifying anatomical regions with known Non-small cell lung cancer and in determining extent of disease in these patients as compared to 18F-FDG PET/CT imaging
End of Study
Study Arms (2)
99 m Tc-EC-DG
EXPERIMENTAL99m Tc-Ec-DG injection followed by SPECT/CT imaging (range 20-30 mCi) 1mg EC-DG
18F-FDG
ACTIVE COMPARATOR18 F FDG injection followed by PET/CT imaging
Interventions
one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG to be injected
Eligibility Criteria
You may qualify if:
- Male or female patients at least 18 years old;
- Have non-incisional biopsy demonstrating definitive evidence for NSCLC (Cytology results confirming NSCLC from a bronchoscope procedure will also be acceptable) 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;
- Stable hormonal contraceptive (oral, topical, vaginal or implanted/injected) for at least 3 months prior to study and through study completion;
- Abstinence;
- Single-barrier method for at least 14 days prior to screening and though study completion for vasectomized males or females with vasectomized partners;
- Have a fasting blood glucose of less than 200 mg/dL at screening;
- Have reported clinical symptoms consistent with a confirmed diagnosis of NSCLC;
- +16 more criteria
You may not qualify if:
- Any clinically significant safety concerns (laboratory, electrocardiogram \[EKG\], 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;
- Undergoing any current treatment for cancer (radiation therapy, surgery or chemotherapy);
- Diabetic with insulin dependence (Patients who have a 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;
- Patient weight above the SPECT/CT and PET/CT table weight limit;
- Failure to have a non-incisional biopsy definitive diagnosis for NSCLC (or cytology report from a bronchoscope); \[a copy of the biopsy/cytology report must be available to the investigator within 28 days of Visit 1\];
- Will not agree to use an effective means of contraception for the duration of the study (males and females);
- Known hypersensitivity to EC-DG or FDG or similar compounds including any of the inactive ingredients;
- Known or suspected pregnancy, lactation or planned pregnancy (females and male partners);
- Clinically significant mental illness (to be determined by the Investigator);
- Exposure to any investigational agent within 30 days prior to screening visit or participating in an ongoing clinical study (this criteria can be overruled by the Principal Investigator with appropriate documentation of the reason for the exception);
- Patient has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell>Point LLClead
- Numodacollaborator
- Venn Life Sciencescollaborator
- Camargo Pharmaceutical Servicescollaborator
- Biomedical Servicescollaborator
Study Sites (6)
Baptist Health South Florida
Coral Gables, Florida, 33143, United States
Decatur Memorial Hospital Department of Radiology
Decatur, Illinois, 62526, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Mayo Clinic, Division of Nuclear Medicine
Rochester, Minnesota, 55905, United States
Montefiore Medical Center, Department of Nuclear Medicine
The Bronx, New York, 10461, United States
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2L7, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Blaufox, MD
Albert Einstein University, Montefiore Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2009
First Posted
March 19, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
March 22, 2013
Record last verified: 2013-03