Pharmacokinetic and Radiation Dosimetry Study Evaluating 99m TC-EC-DG SPECT/CT in Patients With Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Collaborators:
Numoda
VENN Life Services
Camargo Pharmaceutical Services
Biomedical Systems
Information provided by (Responsible Party):
Cell>Point LLC
ClinicalTrials.gov Identifier:
NCT00864110
First received: March 17, 2009
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)
Radiation: Technetium 99m ethylenedicysteine-deoxyglucose
Radiation: 18 F fluorodeoxyglucose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Cell>Point LLC:

Primary Outcome Measures:
  • Safety: through adverse event collection [ Time Frame: from 99mTc-EC-DG injection through 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic (blood) [ Time Frame: 0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetic (urine) [ Time Frame: pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection ] [ Designated as safety issue: No ]
  • Radiation Dosimetry (whole body planar imaging) [ Time Frame: 15 minutes, 2, 4, 6 hours post injection ] [ Designated as safety issue: No ]
  • Comparison of the results of EC-DG:SPECT/CT (als) to biopsy results and FDG:PET/CT (als) [ Time Frame: At end of study ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 99mTc EC-DG
99mTc-EC-DG with SPECT/CT imaging
Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)
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
Radiation: Technetium 99m ethylenedicysteine-deoxyglucose
99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)
Active Comparator: 18F FDG
18F FDG with PET/CT imaging
Radiation: 18 F fluorodeoxyglucose
single injection of 18F FDG (range 10-20 mCi)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    1. Surgically sterile (hysterectomy or bilateral oophorectomy);
    2. Surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Documentation is required;
    3. Intrauterine device (IUD) in place for at least 3 months;
    4. Double-barrier method (condom and diaphragm) with spermicide for at least 14 days prior to screening and through study completion;
    5. Stable hormonal contraceptive (oral, topical, vaginal or implanted/injected) for at least 3 months prior to study and through study completion;
    6. Abstinence;
    7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864110

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Minnesota
Mayo Clinic, Division of Nuclear Medicine
Rochester, Minnesota, United States, 55905
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Cell>Point LLC
Numoda
VENN Life Services
Camargo Pharmaceutical Services
Biomedical Systems
Investigators
Principal Investigator: Donald Blaufox, MD Albert Einstein University, Montefiore Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cell>Point LLC
ClinicalTrials.gov Identifier: NCT00864110     History of Changes
Other Study ID Numbers: CP-05-233
Study First Received: March 17, 2009
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell>Point LLC:
Non small cell lung cancer
SPECT CT imaging
Pharmacokinetic
Radiation Dosimetry
PET CT comparison

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Deoxyglucose
Fluorodeoxyglucose F18
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 14, 2014