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

NCT00864110 | Completed Phase 1 DMC

• 1 other identifier: CP-05-233
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer; SPECT CT imaging; Pharmacokinetic; Radiation Dosimetry; PET CT comparison

Outcome Measures

Primary Outcomes (1)

• Safety: through adverse event collection

  from 99mTc-EC-DG injection through 21 days

Secondary Outcomes (4)

• 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

• Radiation Dosimetry (whole body planar imaging)

  15 minutes, 2, 4, 6 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

Study Arms (2)

99mTc EC-DG

EXPERIMENTAL

99mTc-EC-DG with SPECT/CT imaging

Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose); Radiation: Technetium 99m ethylenedicysteine-deoxyglucose

18F FDG

ACTIVE COMPARATOR

18F FDG with PET/CT imaging

Radiation: 18 F fluorodeoxyglucose

Interventions

Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose) RADIATION

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

Technetium 99m ethylenedicysteine-deoxyglucose RADIATION

99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)

99mTc EC-DG

18 F fluorodeoxyglucose RADIATION

single injection of 18F FDG (range 10-20 mCi)

18F FDG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

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 (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.

Sponsors & Collaborators

• Cell>Point LLC: lead
• Numoda: collaborator
• Venn Life Sciences: collaborator
• Camargo Pharmaceutical Services: collaborator
• Biomedical Systems: collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Mayo Clinic, Division of Nuclear Medicine

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Links

• Location of the study
• Sponsor link

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

technetium 99m ethylenedicysteine deoxyglucose; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Donald Blaufox, MD

  Albert Einstein University, Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (3)