Study of 18F-Fluoro-PEG6-IPQA

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01320059
First received: March 18, 2011
Last updated: September 25, 2014
Last verified: September 2014
  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 2016 (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:
  • PET
  • Imaging

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must give written informed consent
  2. 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.
  3. Patients should be potential candidates for therapy with an EGFR tyrosine kinase inhibitor or with an anti-EGFR monoclonal antibody by clinical criteria.
  4. 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.
  5. Patients should have at least one tumor deposit that is > 1.0 cm in diameter, and that is amenable to imaging
  6. Patients should be ECOG performance status 0-2
  7. 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
  8. 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
  9. The patient must be considered legally capable of providing his or her own consent for participation in this study
  10. Subjects must be at least 18 years of age

Exclusion Criteria:

  1. Radiotherapy, chemotherapy or any investigational agent within the previous 2 weeks of administrating 18F-PEG6-IPQA for PET/CT imaging.
  2. A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  3. Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT imaging.
  4. A tumor that is known to have a K-ras mutation
  5. Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
  6. 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)
  7. 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)
  8. Serum creatinine >1.5 x ULN, bilirubin >1.5 x ULN, AST > 3 x ULN
  9. 10. Hemoglobin < 8 g/dL, absolute neutrophil count < 1,500/mm3, platelet count <100,000/mm3
  10. 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).
  11. 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.
  12. Oxygen saturation <90% on room air
  13. Clinical requirement for systemic corticosteroids for control of cerebral edema or for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for COPD are permitted).
  14. Pregnant or nursing
  15. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320059

Contacts
Contact: Donald Podoloff, MD,BA 713-745-1160

Locations
United States, Texas
University of Texas 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 M.D. 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, W81XWH-05-2-0027, NCI-2014-01375
Study First Received: March 18, 2011
Last Updated: September 25, 2014
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 September 30, 2014