Study of 18F-Fluoro-PEG6-IPQA
A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors
3 other identifiers
interventional
6
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lung-cancer
Started Feb 2012
Typical duration for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 27, 2016
April 1, 2016
4.2 years
March 18, 2011
June 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Safety measurements performed from administration of injection until 2 weeks after administration.
Study Arms (1)
Imaging with 18F-PEG6-IPQA
EXPERIMENTALRadioactive injection given by vein before multiple (3) PET scans.
Interventions
Radioactive injection (PET imaging agent) given by vein before PET scans.
3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
- 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
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- United States Department of Defensecollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Podoloff, MD,BA
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2011
First Posted
March 22, 2011
Study Start
February 1, 2012
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
June 27, 2016
Record last verified: 2016-04