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A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors

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 Research (CABIR).

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 M. D.

Inclusion Criteria:

1. All patients must give written informed consent

2. 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

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 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"

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

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. Prior therapy with an EGFR inhibitor or an anti-EGFR monoclonal antibody

2. Radiotherapy, chemotherapy or any investigational agent within the previous 4 weeks
of administrating 18F-PEG6-IPQA for PET/CT imaging.

3. A non-investigational targeted agent within the previous 2 weeks of 18F-PEG6-IPQA for
PET/CT imaging.

4. Thoracic or abdominal surgery within the previous 2 weeks of 18F-PEG6-IPQA for PET/CT

5. A tumor that is known to have a K-ras mutation

6. Squamous cell, large cell undifferentiated, neuroendocrine or small cell
undifferentiated carcinoma of the lung

7. 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)

8. 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)

9. Serum creatinine >1.5 x ULN, bilirubin >1.5 x ULN, AST > 3 x ULN

10. 10. Hemoglobin < 8 g/dL, absolute neutrophil count < 1,500/mm3, platelet count

11. 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).

12. 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.

13. Oxygen saturation <90% on room air

14. Clinical requirement for systemic corticosteroids for control of cerebral edema or
for enzyme-inducing anticonvulsants. (Inhaled steroids and systemic steroids for COPD
are permitted).

15. Pregnant or nursing

16. 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety

Outcome Description:

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.

Outcome Time Frame:

Safety measurements performed from administration of injection until 2 weeks after administration.

Safety Issue:


Principal Investigator

Donald Podoloff, MD,BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Lung Cancer
  • 18F-Fluoro-PEG6-IPQA
  • Radioactive Imaging Solution
  • Non-Small Cell Lung Cancer
  • Positron Emission Tomography
  • PET Scan
  • CT
  • Computed Tomography
  • Lung Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030