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A Multicenter Phase 3 Study Comparing the Diagnostic Accuracy of 99mTc EC DG SPECT/CT Versus 18F FDG PET/CT for Diagnosing and Staging Patients Who Have Clinical and Radiological (CT) Evidence Consistent With a Diagnosis of Lung Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Multicenter Phase 3 Study Comparing the Diagnostic Accuracy of 99mTc EC DG SPECT/CT Versus 18F FDG PET/CT for Diagnosing and Staging Patients Who Have Clinical and Radiological (CT) Evidence Consistent With a Diagnosis of Lung Cancer


1. To demonstrate that SPECT/CT (99mTc EC DG) is not inferior to PET/CT (18F FDG PET/CT)
for sensitivity or specificity measures when image interpretation of primary and
metastatic lesions are compared against a truth standard in patients with a high
likelihood of lung cancer.

2. To expand the patient safety experience using 99mTc EC DG.


Inclusion Criteria:



1. The subject is a male or female patient at least 18 years old.

2. The subject must agree at the time of enrollment to have the following procedures:

- A tissue diagnosis of the primary lesion either prior to enrollment or within 15
days of the PET/CT study but before initiation of therapy

- A SPECT/CT procedure

- A baseline DCCT scan

- A whole-body bone scan

- A follow-up focused DCCT scan (if indicated)

3. The patient has had a non incisional biopsy demonstrating definitive evidence for
lung cancer OR have clinical evidence and CT scan results consistent with a diagnosis
of lung cancer. Cytology results confirming lung cancer from a bronchoscope procedure
will also be acceptable. A copy of the actual report (biopsy/cytology or CT scan)
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 15 days of the PET imaging
study.

4. The patient will not be receiving treatment for lung cancer (surgery, radiation,
and/or chemotherapy), or, if the patient has had lung cancer in the past, all
previous therapy was completed at least 3 months prior to being enrolled in the
study.

5. If a tissue diagnosis of the primary lesion was not done prior to enrollment, the
patient must agree to have a tissue diagnosis of the primary lesion within 15 days of
the PET/CT study but prior to initiation of therapy, independent of the PET/CT
results.

6. The patient must be referred for a PET/CT scan on the basis of clinical and
radiological (CT) evidence for a diagnosis of lung cancer.

7. The patient will have an Eastern Co-operative Oncology Group (ECOG) performance
rating < or = 2.

8. The patients will be 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).

9. 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 through study
completion for vasectomized males or females with vasectomized partners

10. The patient will have fasting blood glucose of < 200 mg/dL at screening.

11. The patient will have reported clinical symptoms consistent with a diagnosis of lung
cancer.

12. The patient must be able to tolerate SPECT/CT and PET/CT imaging. This includes:

1. lying in the same position without moving for approximately 45 minutes

2. able to tolerate a confined area (ie, not claustrophobic)

3. ability to hold their arms overhead for approximately 45 minutes

13. The patient must be able to fast and/or follow diet restrictions prior to SPECT/CT
and PET/CT imaging.

14. Patients must fast for at least 6 hours prior to the injection for the study.

15. The patient must be able to eat a high protein/low carbohydrate meal as the last meal
before SPECT/CT and PET/CT imaging. However, if the site has its own standard of care
requirements for fasting and/or diet restrictions for PET as an alternative to this
recommendation, the same fasting and/or diet restrictions used for PET imaging should
be applied for the SPECT imaging.

16. The patient must 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 1-15 days after the initial imaging visit, with
at least 24 hours between PET/CT and SPECT/CT imaging).

17. The patient must 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):

1. alanine aminotransferase < or = 2.5 × ULN

2. aspartate aminotransferase < or = 2.5 × ULN

3. creatinine < or = 2.5 × ULN

4. bilirubin < or = 2.0 × ULN

18. The patient must be able to understand and provide signed informed consent.

19. Females of childbearing potential must have a negative urine or serum β-hCG pregnancy
test at screening.

Exclusion Criteria:

1. Any clinically significant safety concerns (laboratory, 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.

2. The patient is undergoing any current treatment for cancer (radiation therapy,
surgery, or chemotherapy).

3. The patient is diabetic with insulin dependence. (Patients who have 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.)

4. The patient's weight is above the SPECT/CT and PET/CT table weight limit.

5. The patient has a known hypersensitivity to EC DG or FDG or similar compounds
including any of the inactive ingredients.

6. The patient has a known or suspected pregnancy, lactation or planned pregnancy
(females and male partners).

7. The patient has clinically significant mental illness (to be determined by the
Investigator).

8. The patient has exposure to any investigational agent within 30 days prior to the
screening visit or is participating in an ongoing clinical study. (This criterion can
be overruled by the Principal Investigator with appropriate documentation of the
reason for the exception.)

9. 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:

Interventional

Study Design:

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

Outcome Measure:

Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions

Outcome Description:

To demonstrate that SPECT/CT (99mTc EC DG) is not inferior to PET/CT (18F FDG PET/CT) for sensitivity or specificity measures when image interpretation of primary and metastatic lesions are compared against a truth standard in patients with a high likelihood of lung cancer.

Outcome Time Frame:

Images will be compared at the core image lab at approximately every 4 to 6 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CP-05-236

NCT ID:

NCT01394679

Start Date:

April 2013

Completion Date:

February 2015

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Recurrent Lung Cancer no treatment within 3 months
  • Lung Neoplasms

Name

Location

Decatur Memorial HospitalDecatur, Illinois  62526