Non Small Cell Lung CancerPhase 1NCT00864110
Pharmacokinetic and Radiation Dosimetry Study Evaluating 99m TC-EC-DG SPECT/CT in Patients With Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose), Technetium 99m ethylenedicysteine-deoxyglucose and 18 F fluorodeoxyglucose in people with Non Small Cell Lung Cancer, run by Cell>Point LLC at 3 sites in United States.
Trial summary
This is a multi-center Phase 1 b study designed to expand the patient safety using 99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy definitive evidence of Non-small Cell Lung Cancer as compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose), Technetium 99m ethylenedicysteine-deoxyglucose and 18 F fluorodeoxyglucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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 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:
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- 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 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.
Who cannot join
- 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 chemotherapy)
- 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);
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- 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 partners);
- 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 exception);
- 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
3 sites in 1 country.
United States3 sites
University of Chicago
Chicago, Illinois, 60637
Mayo Clinic, Division of Nuclear Medicine
Rochester, Minnesota, 55905
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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)
This is a multi-center Phase 1 b study designed to expand the patient safety using 99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.
Read the detailed description
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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose), Technetium 99m ethylenedicysteine-deoxyglucose, 18 F fluorodeoxyglucose
- Keywords
- Non small cell lung cancer, SPECT CT imaging, Pharmacokinetic, Radiation Dosimetry, PET CT comparison
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)Radiation
one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20 mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG will be injected
Technetium 99m ethylenedicysteine-deoxyglucoseRadiation
99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi)
18 F fluorodeoxyglucoseRadiation
single injection of 18F FDG (range 10-20 mCi)
| Study group | Role | What they receive |
|---|---|---|
| 99mTc EC-DG | Experimental | 99mTc-EC-DG with SPECT/CT imaging Receives: Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose); Radiation: Technetium 99m ethylenedicysteine-deoxyglucose |
| 18F FDG | Active comparator | 18F FDG with PET/CT imaging Receives: Radiation: 18 F fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: through adverse event collection
Measured: from 99mTc-EC-DG injection through 21 days
Secondary outcomes (4)
Pharmacokinetic (blood)
Measured: 0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours
Pharmacokinetic (urine)
Measured: pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection
Radiation Dosimetry (whole body planar imaging)
Measured: 15 minutes, 2, 4, 6 hours post injection
Comparison of the results of EC-DG:SPECT/CT (als) to biopsy results and FDG:PET/CT (als)
Measured: At end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell>Point LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Numoda, Venn Life Sciences, Camargo Pharmaceutical Services, Biomedical Systems
- Responsible party
- Sponsor
- Investigators
- Donald Blaufox, MD, Principal investigator, Albert Einstein University, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864110
- Sponsor's protocol ID
- CP-05-233
- Status last verified
- Mar 2013
- First submitted
- 17 Mar 2009
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00864110
- Acronym / sponsor ID
- CP-05-233
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, SPECT CT imaging, Pharmacokinetic, Radiation Dosimetry, PET CT comparison
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cell>Point LLCIndustry (pharma, biotech, devices)
- Collaborators
- Numoda, Venn Life Sciences, Camargo Pharmaceutical Services, Biomedical Systems
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Mar 2009 (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.
This is a multi-center Phase 1 b study designed to expand the patient safety using 99mTc-EC-DG with SPECT/CT imaging and to expand the patient radiation dosimetry and pharmacokinetic database using 99mTc-EC-DG in patients who have non-incisional biopsy definitive evidence of Non-small Cell Lung Cancer as compared to 18F-FDG PET/CT imaging.
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 99mTc EC-DG | Experimental | Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose), Radiation: Technetium 99m ethylenedicysteine-deoxyglucose99mTc-EC-DG with SPECT/CT imaging |
| 18F FDG | Active comparator | Radiation: 18 F fluorodeoxyglucose18F FDG with PET/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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 oophorectomy);
Key exclusion criteria (11 listed)
- 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 chemotherapy)
- 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);
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 |
|---|---|---|
| Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose)one injection of Technetium ethylenedicysteine-deoxyglucose to yield a target activity of 20 mCi (range 20-30 mCi) to be given by slow IV push (over 3-5 minutes) 1mg of EC-DG will be injected | Radiation | 99mTc EC-DG |
| Technetium 99m ethylenedicysteine-deoxyglucose99mTc EC-DG injection, single dose, slow IV push over 3-5 minutes, yielding a target activity of 20 mCi (range 20-30 mCi) | Radiation | 99mTc EC-DG |
| 18 F fluorodeoxyglucosesingle injection of 18F FDG (range 10-20 mCi) | Radiation | 18F FDG |
Primary outcome
Safety: through adverse event collection
Time frame: from 99mTc-EC-DG injection through 21 days
4 secondary outcomes
Pharmacokinetic (blood)
Time frame: 0 hour, post-injection:15 minutes, 1, 2, 4, 6, 24 hours
Pharmacokinetic (urine)
Time frame: pre-injection, 0-2, 2-4, 4-6, 6-24 hours post injection
Radiation Dosimetry (whole body planar imaging)
Time frame: 15 minutes, 2, 4, 6 hours post injection
Comparison of the results of EC-DG:SPECT/CT (als) to biopsy results and FDG:PET/CT (als)
Time frame: At end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Sponsor linkLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Donald Blaufox, MD principal investigator
Albert Einstein University, Montefiore Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose), Technetium 99m ethylenedicysteine-deoxyglucose and 18 F fluorodeoxyglucose in people with Non Small Cell Lung Cancer, run by Cell>Point LLC at 3 sites 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 31 inclusion and 11 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: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: through adverse event collection (time frame: from 99mTc-EC-DG injection through 21 days). 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 22 Mar 2013.