WithdrawnNot Applicable

Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography

Stopped: Unable to use equipment at partner institution.

United States0Started 2023-06-02

Plain-language summary

The purpose of this study is to determine if a new non-invasive imaging technology, called Photoacoustic Computed Tomography (PACT), can be used in the pre-operative setting to better visualize the blood supply of reconstructive flaps used in Plastic Surgery.

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: * Patients above the age of 18 who are planned to undergo non-urgent flap reconstructive surgery, specifically either an abdominally-based flap or an ALT flap, will be study candidates. Exclusion Criteria: * Patients who require urgent or emergent flap reconstructive surgery, have undergone prior abdominally-based or ALT flap reconstructive surgery, who cannot receive ionizing radiation (required for CTA), who cannot receive iodinated intravenous contrast (required for CTA), and whose weight exceeds 300lbs (weight limit of PACT machine) will be excluded from the study.

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.

What they're measuring

PACT Patient Comfort Questionnaire

Timeframe: This questionnaire will be completed by patient at the time of the PACT Imaging visit. Imaging visit will occur after the initial visit and before surgery up to 4 months.

Vascular Imaging Modality for Flap Reconstructive Surgery Questionnaire

Timeframe: This questionnaire will be completed by Dr. Edward Ray immediately following surgery.

Trial details

NCT IDNCT04783272

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Other Reconstructive Surgery trials