Study of 18F-Fluoro-PEG6-IPQA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320059
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : June 27, 2016
United States Department of Defense
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: 18F-PEG6-IPQA Procedure: Positron emission tomography (PET) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Eastern Cooperative Oncology Group (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 upper limit of normal (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 chronic obstructive pulmonary disease (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320059

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
United States Department of Defense
Principal Investigator: Donald Podoloff, MD,BA M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01320059     History of Changes
Other Study ID Numbers: 2009-0832
W81XWH-05-2-0027 ( Other Identifier: DOD )
NCI-2014-01375 ( Registry Identifier: NCI CTRP )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: April 2016

Keywords provided by M.D. Anderson Cancer Center:
Radioactive Imaging Solution
Non-Small Cell Lung Cancer
Positron Emission Tomography
PET Scan
Computed Tomography