Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04565457
Eligibility Criteria:
Inclusion Criteria:
1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a male or female aged 18-100.
4. Participants who will be treated or are currently being treated with CBCT-guided photon therapy for prostate or prostate-bed, abdomen head and neck, or pelvic cancers, or with image-guided proton therapy for prostate or prostate bed cancer.
Exclusion Criteria:
1. Metallic implants in the CBCT scan volume, such as hip prostheses or spine stabilization hardware. Patients with pacemakers, defibrillators, or other implanted electronic devices. Dental implants, fillings, or fiducial markers may be acceptable, and the decision for inclusion/exclusion will be on a case-by-case basis, by reviewing prior CT images of the study candidate. Patient's prior CT images will be reviewed by the PI or the site PI.
2. Patients who do not have the ability to lie still for the duration of his/her CBCT imaging and treatment should be excluded. If image artifacts in prior scans are deemed excessive, the patient will be excluded from the study.
3. Known pregnancy. (Per SOC, a pregnancy test will be performed prior to CBCT scan on Day 1. At this time, women of child-bearing potential (WOCBP) will receive a pregnancy test to re-confirm eligibility).
* Women of child-bearing potential are described as:
1. Age 55 or younger who have not had a negative pregnancy test within 3 days. This excludes patients who have had tubal ligation or are already post-menopausal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04565457
Study Brief:
Protocol Section:
NCT04565457