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:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT05611905
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥18 years of age at the time of consent and imaging.
2. Healthy subjects OR those with confirmed (microbiologically, molecular or serological testing) diagnosis of infection at any body site OR clinical and imaging evidence of suspected infection in any body site with confirmation (microbiologically, molecular or serological testing) anticipated within 72 hours of imaging.
OR subjects with confirmed inflammatory (rheumatoid arthritis, idiopathic pulmonary fibrosis, etc) or oncologic (e.g. localized or metastatic tumors) disease and clinically determined not to have infection.
3. For subjects with infections:
Non mycobacterium tuberculosis infections: received no more than 7 days of effective antibiotic treatment, as judged by the attending and/or principal investigator.
OR Mycobacterium tuberculosis or mycobacteroides infections: received no more than 4 weeks of effective treatment. Infection confirmed by positive culture or molecular testing.
4. For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).
5. Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
6. Subjects or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Adults lacking capacity will not be enrolled in this study.
Exclusion criteria:
Within 28 or fewer days prior to imaging, a complete blood count with differential, blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:
1. Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) at screening and positive urine hCG prior to radiopharmaceutical dosing.
2. Lactating females.
3. Inadequate venous access.
4. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the principal investigator.
5. Administered a radioisotope within 5 physical half-lives prior to study enrollment.
6. Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration.
7. Determined to have prior (external) radiation exposure which will exceed RDRC annual radiation exposure limit of 5 rems.
8. For patients undergoing renal imaging they will be excluded if any of the following conditions exist:
* Hypertension
* Diabetes mellitus type I or II
* Body mass index less than 18.5 kg/m2 or higher than 30 kg/m2
* Family history of renal disease
* Urinary tract infection in the prior 6 months
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05611905
Study Brief:
Protocol Section:
NCT05611905