18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients

Official record

Identifier

NCT03168737

Recruiting locations

country

United States

Interventions studied

Computed TomographyFluorine F 18-fluoroazomycin ArabinosidePositron Emission Tomography

Lead sponsor

M.D. Anderson Cancer Center

Target enrolment

25 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Active, not recruiting

First posted

May 30, 2017

Last updated on the registry

Jul 30, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.