Clinical trial NCT03168737: 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
Official title: Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Malignant Breast Neoplasm
Malignant Colorectal Neoplasm
Malignant Pancreatic Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-05-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside (\[18F\]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors.

SECONDARY OBJECTIVES:

I. To determine the variability of imaging findings from repeated \[18F\]FAZA PET-CT studies over \>= 24 hours up to 10 days.

II. To confirm the safety of \[18F\]FAZA administered during PET-CT imaging of hypoxia of solid tumors.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (IV) and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

GROUP B: Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days.

After completion of study treatment, patients are followed up at 24 hours and at 30 days.

Eligibility criteria: Inclusion Criteria:

* Patients with histopathologic diagnosis of a solid tumor. All solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized.
* Patient must have a solid tumor with a short-axis greater than or equal to 1 cm (by CT, magnetic resonance imaging \[MRI\], ultrasonography or mammography) to allow reliable PET imaging.
* A patient who has not received systemic or loco-regional treatment of the tumor within the last month.
* Ability of the subject, or the legally authorized representative (LAR) if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, to understand, and the willingness to sign, a written informed consent.
* Patients who are not expected to receive cancer therapy before imaging sessions are completed.

Exclusion Criteria:

* Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\] FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before accrual after informed consent is obtained.
* Lactation should be suspended for at least two days following the administration of \[18F\] FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
* Subjects with contraindications to the use of \[18F\] FAZA including confirmed allergy.
* Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because the findings will probably be compromised in image quality with CT, PET/CT and MRI.
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Relative change of imaging parameters (tumor volume, standardized uptake value [SUV], tumor to muscle ratio [TMR], hypoxic tumor volume [HTV1, HTV2], and total lesion hypoxia [TLH1, TLH2])
timeFrame: Baseline up to 30 days
measure: Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.03
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Franklin C Wong
role: PRINCIPAL_INVESTIGATOR
References: