F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

American College of Radiology - Image Metrix

Status and phase

Unknown

Phase 3

Conditions

Bone Metastases

Treatments

Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00882609

AMI-2008-01

Details and patient eligibility

About

The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.

Full description

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria.

Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site.

The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.

Enrollment

550 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is ≥ 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
Patient or patient's legally acceptable representative cognitively provides written informed consent
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer
Patient is scheduled to undergo a conventional bone scan
Patient is capable of complying with study procedures
Patient is able to remain still for duration of imaging procedure (about one hour)
Patient may have had a prior PET or PET/CT scan for staging/restaging.

Exclusion criteria

Patient is < 18 years old at the time of the drug administration
Patient is pregnant or nursing;
- testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
- obtaining surgical history (e.g., tubal ligation or hysterectomy)
- confirming the subject is post menopausal, with a minimum 1 year without menses
Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
Patient has known bone metastases
Patient has previously received [18F]NaF in the last thirty days

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

550 participants in 2 patient groups

TC-MDP Bone Scan

Active Comparator group

Description:

Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA \>10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan

Treatment:

Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP

F18-Fluoride PET/CT

Experimental group

Description:

Treatment:

Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP