Study of 18F-Fluoro-PEG6-IPQA
This study is currently recruiting participants.
Verified December 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01320059
First received: March 18, 2011
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: 18F-PEG6-IPQA Procedure: Positron emission tomography (PET) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]Safety endpoints summarized by counts and percents by tumor type: Occurrence of one or more changes from baseline, at each post-treatment time point, greater than 40% and 80% of span of the normal limits; or, Occurrence of post-treatment values that are changes greater than 80% of the span of the normal limits.
| Estimated Enrollment: | 15 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Imaging with 18F-PEG6-IPQA
Radioactive injection given by vein before multiple (3) PET scans.
|
Drug: 18F-PEG6-IPQA
Radioactive injection (PET imaging agent) given by vein before PET scans.
Procedure: Positron emission tomography (PET)
3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients must give written informed consent
- Patients should have pathologically or cytologically confirmed non-small cell lung cancer with clinical or radiological evidence that it is not amenable to therapy with curative intent
- 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 either: "Less than a 10 pack-year smoking history AND a latency period from last tobacco use to diagnosis of longer than 10 years AND either lung adenocarcinoma or NSCLC not otherwise specified, OR "Known EGFR mutations OR high EGFR 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 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
Exclusion Criteria:
- Prior therapy with an EGFR inhibitor or an anti-EGFR monoclonal antibody
- Radiotherapy, chemotherapy or any investigational agent within the previous 4 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 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320059
Contacts
| Contact: Donald Podoloff, MD,BA | 713-745-1160 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Donald Podoloff, MD,BA | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01320059 History of Changes |
| Other Study ID Numbers: | 2009-0832 |
| Study First Received: | March 18, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
18F-Fluoro-PEG6-IPQA Radioactive Imaging Solution Non-Small Cell Lung Cancer Positron Emission Tomography |
PET Scan CT Computed Tomography |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013