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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)

Phase 1
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

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)

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).

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

- 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

- 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

- 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: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Safety: through adverse event collection

Outcome Time Frame:

from 99mTc-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:




Start Date:

April 2010

Completion Date:

December 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non small cell lung cancer
  • SPECT CT imaging
  • Pharmacokinetic
  • Radiation Dosimetry
  • PET CT comparison
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Montefiore Medical CenterBronx, New York  10467-2490
University of ChicagoChicago, Illinois  60637
Mayo Clinic, Division of Nuclear MedicineRochester, Minnesota  55905