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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)

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

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)

Male and female patients at least 18 years of age with untreated Non-small Cell Lung Cancer
who have non-incisional biopsy definitive evidence of disease (or from cytology results from
a bronchoscope procedure) 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 99m Tc-Ec-DG SPECT/CT. The study procedures can be performed
within 5-7 days of signing the informed consent. [To better meet the standard of care at
each clinical location, the PET/CT can be performed as part of pre-study procedures on a
PET/CT camera previously qualified by the site to meet the standards required for the study.
If this occurs, the SPECT/CT must be performed within 45 days of the PET/CT imaging
procedures.] Patients will be seen 24 hours after the 99m Tc-Ec-DG injection for safety. 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.]

Inclusion Criteria:

- 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

- 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 (or follow site specific fasting and/or diet

- A morning scan (08:00-12:00) will require fasting from midnight;

- An afternoon scan (12:00-onward) will require a minimum 6 hour fast;

- Be able to eat a high protein/low carbohydrate meal as the last meal before SPECT/CT
and PET/CT imaging (or follow site specific fasting and/or 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 was done as part of the
pre-screening procedures and was conducted on a previously qualified PET camera for
the study, the SPECT/CT must be done within 45 days of the PET/CT imaging procedures;

- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Safety: Through adverse event collection

Outcome Time Frame:

from 99m Tc-Ec-DG injection through 21 days

Safety Issue:


Principal Investigator

Donald Blaufox, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein University, Montefiore Medical Center


United States: Food and Drug Administration

Study ID:

CP-05-232 Amendment 1



Start Date:

June 2009

Completion Date:

December 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • Spect CT Imaging
  • PET CT Imaging as Comparator
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



John Hopkins UniversityBaltimore, Maryland  21231
Mayo Clinic, Division of Nuclear MedicineRochester, Minnesota  55905
Baptist Health South FloridaCoral Gables, Florida  33143
Decatur Memorial Hospital Department of RadiologyDecatur, Illinois  62526
Montefiore Medical Center, Department of Nuclear MedicineBronx, New York  10461