Lung CancerPhase 3NCT01394679
A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer
A Phase 3 study testing (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) and 18 F FDG followed by PET/CT imaging in people with Lung Cancer, run by Cell>Point LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) and 18 F FDG followed by PET/CT imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- 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 through study completion for vasectomized males or females with vasectomized partners
- The patient will have fasting blood glucose of < 200 mg/dL at screening.
- The patient will have reported clinical symptoms consistent with a diagnosis of lung cancer.
- The patient must be able to tolerate SPECT/CT and PET/CT imaging. This includes:
- lying in the same position without moving for approximately 45 minutes
- able to tolerate a confined area (ie, not claustrophobic)
- ability to hold their arms overhead for approximately 45 minutes
- The patient must be able to fast and/or follow diet restrictions prior to SPECT/CT and PET/CT imaging.
- Patients must fast for at least 6 hours prior to the injection for the study.
- 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.
- 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).
- 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):
- alanine aminotransferase < or = 2.5 × ULN
- aspartate aminotransferase < or = 2.5 × ULN
- creatinine < or = 2.5 × ULN
- bilirubin < or = 2.0 × ULN
- The patient must be able to understand and provide signed informed consent.
- Females of childbearing potential must have a negative urine or serum β-hCG pregnancy test at screening.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the detailed 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.
- To expand the patient safety experience using 99mTc EC DG.
- Conditions
- Lung Cancer
- Being tested
- (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose), 18 F FDG followed by PET/CT imaging
- Keywords
- Lung Cancer, Recurrent Lung Cancer no treatment within 3 months
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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
18 F FDG followed by PET/CT imagingDrug
Single injection of 18 F FDG range of 10-20 mCi
| Study group | Role | What they receive |
|---|---|---|
| 18-F-FDG Imaging Agent | Active comparator | 18 F FDG followed by PET/CT imaging Receives: 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 Receives: Drug: (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Images will be compared at the core image lab at approximately every 4 to 6 weeks
Secondary outcomes (1)
Safety:Through Adverse Event Collection
Measured: From 99m-Tc-EC-DG injection up to 90 days post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study start1 May 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients receive Standard PET imaging with FDG then receive SPECT-CT imaging with investigational EC-DG imaging agent
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell>Point LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cynthia Phurrough, BS, Study director, Consultanat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394679
- Sponsor's protocol ID
- CP-05-236
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2011
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01394679
- Acronym / sponsor ID
- CP-05-236
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Recurrent Lung Cancer no treatment within 3 months
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Cell>Point LLCIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- To expand the patient safety experience using 99mTc EC DG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients receive Standard PET imaging with FDG then receive SPECT-CT imaging with investigational EC-DG imaging agent
| Arm | Type | Receives |
|---|---|---|
| 18-F-FDG Imaging Agent | Active comparator | Drug: 18 F FDG followed by PET/CT imaging18 F FDG followed by PET/CT imaging |
| 99m Tc-EC-DG imaging agent | Experimental | Drug: (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)99m Tc-EC-DG injection followed by SPECT/CT imaging (target of 20-30 mCi of Tc)and < 1 mg EC-DG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)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 | Drug | 99m Tc-EC-DG imaging agent |
| 18 F FDG followed by PET/CT imagingSingle injection of 18 F FDG range of 10-20 mCi | Drug | 18-F-FDG Imaging Agent |
Primary outcome
Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions
Time frame: Images will be compared at the core image lab at approximately every 4 to 6 weeks
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.
1 secondary outcome
Safety:Through Adverse Event Collection
Time frame: From 99m-Tc-EC-DG injection up to 90 days post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Phurrough, BS study director
Consultanat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose) and 18 F FDG followed by PET/CT imaging in people with Lung Cancer, run by Cell>Point LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Colip, JD (281-288-4643, gcolip@sbcglobal.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Images will be compared at the core image lab at approximately every 4 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.