- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864110
Pharmacokinetic and Radiation Dosimetry Study Evaluating 99m TC-EC-DG SPECT/CT in Patients With Non-small Cell Lung Cancer (NSCLC)
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)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic, Division of Nuclear Medicine
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New York
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Bronx, New York, United States, 10461
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
- 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;
- 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:
- A morning scan (08:00-12:00) will require fasting from midnight (or as per the site's fasting/diet restrictions);
- An afternoon scan (12:00-onward) will require a minimum 6 hour fast (or as per the site's fasting/diet restrictions);
- 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):
- Alanine aminotransferase 2.5 × upper limit of normal (ULN);
- Aspartate aminotransferase 2.5 × ULN;
- Creatinine 2.5 × ULN;
- Bilirubin 2.0 × ULN;
- 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
- 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 (or cytology report from a bronchoscope) for NSCLC (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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 99mTc EC-DG
99mTc-EC-DG with SPECT/CT imaging
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one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20 mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG will be injected
99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)
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Active Comparator: 18F FDG
18F FDG with PET/CT imaging
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single injection of 18F FDG (range 10-20 mCi)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: through adverse event collection
Time Frame: from 99mTc-EC-DG injection through 21 days
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from 99mTc-EC-DG injection through 21 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic (blood)
Time Frame: 0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours
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0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours
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Pharmacokinetic (urine)
Time Frame: pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection
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pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection
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Radiation Dosimetry (whole body planar imaging)
Time Frame: 15 minutes, 2, 4, 6 hours post injection
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15 minutes, 2, 4, 6 hours post injection
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Comparison of the results of EC-DG:SPECT/CT (als) to biopsy results and FDG:PET/CT (als)
Time Frame: At end of study
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At end of study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donald Blaufox, MD, Albert Einstein University, Montefiore Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
- Deoxyglucose
Other Study ID Numbers
- CP-05-233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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