Lung CancerPhase 1NCT01320059
Study of 18F-Fluoro-PEG6-IPQA
A Phase 1 study testing 18F-PEG6-IPQA and Positron emission tomography (PET) in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if an imaging solution called 18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans. The safety of the solution and how the solution is processed by your body will also be studied. 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?
- 18F-PEG6-IPQA and Positron emission tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Apr 2016
- 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
- All patients must give written informed consent
- Patients should have pathologically or cytologically confirmed Stage IV non-small cell lung cancer with clinical or radiological evidence that it is not amenable to therapy with curative intent. Prior EGFR tyrosine kinase inhibition (TKI) therapy is permitted but not required.
- Patients should be potential candidates for therapy with an EGFR tyrosine kinase inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.
- Patients should have clinical characteristics that would suggest an increased probability of benefit from an EGFR inhibitor. Specifically, they should have known EGFR mutations or high gene copy number.
- Patients should have at least one tumor deposit that is > 1.0 cm in diameter, and that is amenable to imaging
- Patients should be Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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- Patients with brain metastases are eligible provided they meet all other eligibility criteria and do not require corticosteroids or enzyme-inducing anticonvulsants and provided it is felt clinically that they will not require radiotherapy in the three (3) weeks subsequent to their participation in the study
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. The patient, if a man, agrees to use effective contraception or abstinence
- The patient must be considered legally capable of providing his or her own consent for participation in this study
- Subjects must be at least 18 years of age
Who cannot join
- Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks of administrating 18F-PEG6-IPQA for PET/CT imaging.
- A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
- Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
- A tumor that is known to have a K-ras mutation
- Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
- A known other currently active malignancy. (Benign tumors and benign polyps, basal cell carcinomas of skin, superficial papillary bladder tumors, and pre-invasive carcinoma of the cervix are permitted)
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- Physical inability to undergo a scanning procedure (e.g., inability to lie flat for the required period of time - three sessions of roughly an hour each with ten minutes' rest in between)
- Serum creatinine >1.5 x upper limit of normal (ULN), bilirubin >1.5 x ULN, AST > 3 x ULN
- 10. Hemoglobin < 8 g/dL, absolute neutrophil count < 1,500/mm3, platelet count <100,000/mm3
- Potentially life-threatening arrhythmia; myocardial infarct within the previous 3 months; unstable angina, or angina at rest; congestive heart failure (New York Heart Association Functional Classification class II or worse), uncontrolled hypertension (systolic BP > 160 or diastolic BP >100).
- Active acute infection (i.e. currently treated with antibiotics). Patients with chronic infections such as hepatitis B or C, mycobacterium avium or similar infections will be eligible provided they meet all other eligibility criteria.
- Oxygen saturation <90% on room air
- Clinical requirement for systemic corticosteroids for control of cerebral edema or for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for chronic obstructive pulmonary disease (COPD) are permitted).
- Pregnant or nursing
- Any condition that is unstable or could jeopardize the safety of the patient and his or her compliance in the study, in the investigator's judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors
The goal of this clinical research study is to learn if an imaging solution called 18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans. The safety of the solution and how the solution is processed by your body will also be studied.
Read the detailed description
18F-PEG6-IPQA is a solution that is designed to be attracted to tumor cells. The imaging solution has a small dose of radiation added to it, which may help doctors see the cancer cells better during imaging scans. This is the first study using 18F-PEG6-IPQA in humans.
Study Imaging:
If you are found to be eligible to take part in this study, you will visit the clinic on Day 1 for the injection of the study solution and PET scans. This imaging study will be performed at FDA-cleared PET-CT scanners at MD Anderson sites, including at the Center for Advanced Biomedical Imaging (CABI).
For up to 6 hours before the PET scans and computed tomography (CT) scans, you must not eat or drink anything except water. This is called fasting.
A small tube will be placed in your arm and you will receive an injection of 18F-PEG6-IPQA.
After the injection, scanning will begin immediately. You will have 3 PET scanning sessions with a PET/CT scanner. Before each PET scan, you will have a CT scan to make sure you are in the right position for the PET scans. Each PET scan may last up to 1 hour. Each positioning CT scan should take about 5 minutes. You will have a 10 minute "rest period" between each PET scan.
Study Visits:
On Day 1:
- Before the imaging solution is injected, your vital signs and an ECG rhythm strip will be collected. The study staff will insert an intravenous (IV) needle and line into each of your arms.
- Right after the injection of the study drug, blood (about 2 tablespoons total) will be drawn for pharmacokinetic (PK) testing from one of the existing IV lines. PK testing measures the amount of study solution in the body at different time points. Blood will be drawn at 1, 3, 8, 16, 30, 45, 60, 90, and 150 minutes after the injection of 18F-PEG6-IPQA for a total of 9 draws.
- About 30 minutes after the injection, your vital signs will be measured and the injection site will be checked.
- Urine will be collected during the 10 minute rest periods in between scans or at the completion of the 3-hour scanning period.
- After the scans are completed (about 3 hours after the injection) your vital signs and injections site will be checked again, and you will have an ECG rhythm strip taken. Blood (about 2 tablespoons) and urine will also be collected for routine tests.
On Days 2 and 7:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- Your vital signs and the injection site will be checked
- You will be asked about any side effects you may be having since the injection.
End-of-Study Visit:
The end-of-study visit will be about 14 days after the injection of 18F-PEG6-IPQA and imaging scans. The following tests and procedures will be performed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- The injection site will be checked.
- You will have an ECG.
Length of Study:
You will be in this study for about 14 days. You will be taken off study early if intolerable side effects occur.
This is an investigational study. 18F-PEG6-IPQA is not FDA-approved or commercially available for use in imaging scans. Its use in this study is investigational.
The scans performed with 18F-PEG6-IPQA are also considered investigational and will not be used for planning any of your future cancer treatment.
Up to 15 patients will take part in this study. All participants will be enrolled at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- 18F-PEG6-IPQA, Positron emission tomography (PET)
- Keywords
- 18F-Fluoro-PEG6-IPQA, Radioactive Imaging Solution, Non-Small Cell Lung Cancer, Positron Emission Tomography, PET Scan, CT, Computed Tomography
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PEG6-IPQADrug
Radioactive injection (PET imaging agent) given by vein before PET scans.
Positron emission tomography (PET)Procedure or surgery
Also called PET, Imaging
3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Imaging with 18F-PEG6-IPQA | Experimental | Radioactive injection given by vein before multiple (3) PET scans. Receives: Drug: 18F-PEG6-IPQA; Procedure: Positron emission tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety
Optimum dosimetry of 18F-PEG6-IPQA injection for each cohort derived from previous cohort based on statistical evaluation of critical organ exposure and safety limitations. Safety measurements performed from administration of 18F-PEG6-IPQA injection until 2 weeks after administration. The biodistribution of 18F-PEG6-IPQA will be measured during positron emission tomography (PET) scans. The percent injected dose (%ID) obtained in different organs will be derived from the PET data.
Measured: Safety measurements performed from administration of injection until 2 weeks after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2016
- Study completionApr 2016
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Donald Podoloff, MD,BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320059
- Sponsor's protocol ID
- 2009-0832
- Other IDs
- W81XWH-05-2-0027, NCI-2014-01375
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2011
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors
- ClinicalTrials.gov ID
- NCT01320059
- Acronym / sponsor ID
- 2009-0832
- Conditions
- Lung Cancer
- Keywords
- 18F-Fluoro-PEG6-IPQA, Radioactive Imaging Solution, Non-Small Cell Lung Cancer, Positron Emission Tomography, PET Scan, CT, Computed Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Mar 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 goal of this clinical research study is to learn if an imaging solution called 18F-PEG6-IPQA can help to find tumors when used in positron emission tomography (PET) scans. The safety of the solution and how the solution is processed by your body will also be studied.
Detailed description
18F-PEG6-IPQA is a solution that is designed to be attracted to tumor cells. The imaging solution has a small dose of radiation added to it, which may help doctors see the cancer cells better during imaging scans. This is the first study using 18F-PEG6-IPQA in humans.
Study Imaging:
If you are found to be eligible to take part in this study, you will visit the clinic on Day 1 for the injection of the study solution and PET scans. This imaging study will be performed at FDA-cleared PET-CT scanners at MD Anderson sites, including at the Center for Advanced Biomedical Imaging (CABI).
For up to 6 hours before the PET scans and computed tomography (CT) scans, you must not eat or drink anything except water. This is called fasting.
A small tube will be placed in your arm and you will receive an injection of 18F-PEG6-IPQA.
After the injection, scanning will begin immediately. You will have 3 PET scanning sessions with a PET/CT scanner. Before each PET scan, you will have a CT scan to make sure you are in the right position for the PET scans. Each PET scan may last up to 1 hour. Each positioning CT scan should take about 5 minutes. You will have a 10 minute "rest period" between each PET scan.
Study Visits:
On Day 1:
- Before the imaging solution is injected, your vital signs and an ECG rhythm strip will be collected. The study staff will insert an intravenous (IV) needle and line into each of your arms.
- Right after the injection of the study drug, blood (about 2 tablespoons total) will be drawn for pharmacokinetic (PK) testing from one of the existing IV lines. PK testing measures the amount of study solution in the body at different time points. Blood will be drawn at 1, 3, 8, 16, 30, 45, 60, 90, and 150 minutes after the injection of 18F-PEG6-IPQA for a total of 9 draws.
- About 30 minutes after the injection, your vital signs will be measured and the injection site will be checked.
- Urine will be collected during the 10 minute rest periods in between scans or at the completion of the 3-hour scanning period.
- After the scans are completed (about 3 hours after the injection) your vital signs and injections site will be checked again, and you will have an ECG rhythm strip taken. Blood (about 2 tablespoons) and urine will also be collected for routine tests.
On Days 2 and 7:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- Your vital signs and the injection site will be checked
- You will be asked about any side effects you may be having since the injection.
End-of-Study Visit:
The end-of-study visit will be about 14 days after the injection of 18F-PEG6-IPQA and imaging scans. The following tests and procedures will be performed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- The injection site will be checked.
- You will have an ECG.
Length of Study:
You will be in this study for about 14 days. You will be taken off study early if intolerable side effects occur.
This is an investigational study. 18F-PEG6-IPQA is not FDA-approved or commercially available for use in imaging scans. Its use in this study is investigational.
The scans performed with 18F-PEG6-IPQA are also considered investigational and will not be used for planning any of your future cancer treatment.
Up to 15 patients will take part in this study. All participants will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging with 18F-PEG6-IPQA | Experimental | Drug: 18F-PEG6-IPQA, Procedure: Positron emission tomography (PET)Radioactive injection given by vein before multiple (3) PET scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients must give written informed consent
- Patients should have pathologically or cytologically confirmed Stage IV non-small cell lung cancer with clinical or radiological evidence that it is not amenable to therapy with curative intent. Prior EGFR tyrosine kinase inhibition (TKI) therapy is permitted but not required.
- Patients should be potential candidates for therapy with an EGFR tyrosine kinase inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.
- Patients should have clinical characteristics that would suggest an increased probability of benefit from an EGFR inhibitor. Specifically, they should have known EGFR mutations or high gene copy number.
- Patients should have at least one tumor deposit that is > 1.0 cm in diameter, and that is amenable to imaging
Key exclusion criteria (15 listed)
- Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks of administrating 18F-PEG6-IPQA for PET/CT imaging.
- A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
- Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
- A tumor that is known to have a K-ras mutation
- Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
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 |
|---|---|---|
| 18F-PEG6-IPQARadioactive injection (PET imaging agent) given by vein before PET scans. | Drug | Imaging with 18F-PEG6-IPQA |
| Positron emission tomography (PET)Also: PET, Imaging3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours. | Procedure or surgery | Imaging with 18F-PEG6-IPQA |
Primary outcome
Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety
Time frame: Safety measurements performed from administration of injection until 2 weeks after administration.
Optimum dosimetry of 18F-PEG6-IPQA injection for each cohort derived from previous cohort based on statistical evaluation of critical organ exposure and safety limitations. Safety measurements performed from administration of 18F-PEG6-IPQA injection until 2 weeks after administration. The biodistribution of 18F-PEG6-IPQA will be measured during positron emission tomography (PET) scans. The percent injected dose (%ID) obtained in different organs will be derived from the PET data.
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 27 Jun 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 Podoloff, MD,BA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-PEG6-IPQA and Positron emission tomography (PET) in people with Lung Cancer, run by M.D. Anderson Cancer Center 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 10 inclusion and 15 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 27 Jun 2016. 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 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?
Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety (time frame: Safety measurements performed from administration of injection until 2 weeks after administration.). 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 27 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.