Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Befor… (NCT06574178) | Clinical Trial Compass
RecruitingNot Applicable
Use of Total-Body PET to Quantify Systemic and Cutaneous Inflammation in Psoriasis Patients Before and After Intervention With a Nutritionally Balanced Diet
United States5 participantsStarted 2025-01-01
Plain-language summary
Psoriasis is a chronic inflammatory disease that affects the skin and joints in 2-3 % of people in the United States. This inflammation of the skin, joints, and blood vessels in patients with psoriasis has been measured by older PET Scan technology but with limitations. With the new EXPLORER PET scanner technology, the investigators are testing to see if the EXPLORER is better than previous PET scanners and improve our ability to assess inflammation in patients.
Also, it is known that the typical Western Diet - high in saturated fats, added sugars, and low in fiber - contributes to obesity and inflammation worldwide. There is evidence in animals that these signs of inflammation are reversible within 4 weeks when changed to a more balanced diet. Thus, this study aims to assess whether there are detectable decreases in inflammation of the skin and body of psoriasis patients who usually eat a Western Diet on an EXPLORER PET scan following 6 weeks of a more balanced diet.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (\>18 year)
* Both sexes
* Must have a history of psoriasis of at least 3% body surface area affected by skin psoriasis (in a body area that the subject will allow the PI to perform several skin biopsies as noted below (optional)) and may carry a diagnosis of psoriatic arthritis as well
* Patients will have a BMI of \>/=25 which is consistent with being overweight - Willing and able to fast for at least 6 hours before and for the duration of the scan visit
* No strenuous exercise for 24 hours prior to being scanned
* Recruited patients must habitually consume a WD-type diet that will be evaluated by using DHQ III food frequency questionnaire along with three-day food record14. Subsequently, the Healthy Eating Index will be calculated and participants with a poor dietary pattern (score below 58) will be eligible for the study15.
Exclusion Criteria:
* Those taking anti-diabetic oral or injected medications
* Those already ingesting a caloric- or component-restricted diet
* Vegan, vegetarian or food allergy or intolerance to the ingredients of the diet
* \>5% change in body weight in the last 2 months
* Those taking systemic medications for the purpose of treating psoriasis or psoriatic arthritis for at least 3 months prior to first PET scan or during the duration of the trial
* Self-reported history of dysphoria or anxiety in closed spaces (claustrophobia)
* Uncontrolled diabetes or blood glucose level greater than 180 mg/dl at the time of radiot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.