A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer

NCT01394679 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CP-05-236
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the images of the primary lesions of lung cancer and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the same as the PET/CT 18F-FDG scans.

Conditions

Lung Cancer

Keywords

Lung Cancer; Recurrent Lung Cancer no treatment within 3 months

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• Safety:Through Adverse Event Collection

  From 99m-Tc-EC-DG injection up to 90 days post-injection

Study Arms (2)

18-F-FDG Imaging Agent

ACTIVE COMPARATOR

18 F FDG followed by PET/CT imaging

Drug: 18 F FDG followed by PET/CT imaging

99m Tc-EC-DG imaging agent

EXPERIMENTAL

99m Tc-EC-DG injection followed by SPECT/CT imaging (target of 20-30 mCi of Tc)and \< 1 mg EC-DG

Drug: (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)

Interventions

(99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) DRUG

One injection of Technetium-99m Ethylenedicysteine-Deoxyglucose to yield a target dose of 25 mCi (range of 20-30 mCi)by IV push and less than 1 mg of EC-DG

99m Tc-EC-DG imaging agent

18 F FDG followed by PET/CT imaging DRUG

Single injection of 18 F FDG range of 10-20 mCi

18-F-FDG Imaging Agent

Eligibility Criteria

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

You may qualify if:

• The subject is a male or female patient at least 18 years old.
• 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)
• 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.
• 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.
• 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.
• 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.
• The patient will have an Eastern Co-operative Oncology Group (ECOG) performance rating \< or = 2.
• 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).
• 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)

You may not qualify if:

• 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.
• The patient is undergoing any current treatment for cancer (radiation therapy, surgery, or chemotherapy).
• 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.)
• The patient's weight is above the SPECT/CT and PET/CT table weight limit.
• The patient has a known hypersensitivity to EC DG or FDG or similar compounds including any of the inactive ingredients.
• The patient has a known or suspected pregnancy, lactation or planned pregnancy (females and male partners).
• The patient has clinically significant mental illness (to be determined by the Investigator).
• 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.)
• 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.

Sponsors & Collaborators

• Cell>Point LLC: lead

Study Sites (1)

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

(99m)Tc ethylenedicysteine-deoxyglucose

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cynthia Phurrough, BS

  Consultanat

  STUDY DIRECTOR

Central Study Contacts

Greg Colip, JD

CONTACT

281-288-4643; gcolip@sbcglobal.net

Cynthia Phurrough, BS

CONTACT

513-618-0337; cphurrough@camargopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients receive Standard PET imaging with FDG then receive SPECT-CT imaging with investigational EC-DG imaging agent

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 14, 2011
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)