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Other Reconstructive SurgeryNCT04783272

Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography

A study testing Photoacoustic Computed Tomography (PACT) Imaging in people with Other Reconstructive Surgery and Plastic Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Other Reconstructive Surgery, Plastic Surgery
What is being tested?
Photoacoustic Computed Tomography (PACT) Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
2 Jun 2023to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

Official title: Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography - Pilot Study

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.

Read the detailed description

Photoacoustic Computed Tomography (PACT) is a novel, non-invasive imaging technique which can perform deep tissue imaging with high spatial resolution and optical contrast. The system utilizes short-pulsed lasers to generate photoacoustic waves in biological tissues. These are then detected by a 512-element full-ring transducer array, which allows for high spatial resolution, especially in deep tissues. In addition, PACT utilizes diffuse optical tomography, in which the light absorption of hemoglobin at visible or near-infrared wavelengths, provides excellent contrast for the imaging of human vasculature.

Prior studies of PACT imaging have evaluated this technique to image the human breast as an alternative modality for breast cancer screening as well as to image human extremities for the evaluation of vascular disease. The full-ring transducer array offers a significant advantage in spatial resolution, especially in deep tissues, over the standard linear arrays employed in the standard, widely-used handheld ultrasonic transducers. In addition, diffuse optical tomography allows for strong vascular contrast over a large field of view without the use of exogenous contrast agents.

Flap reconstructive surgery utilizes a patient's own soft tissues to recreate structures, fill large soft tissue defects, provide joint coverage, or perform other reconstructive operations. Examples of patients who would require flap reconstructive surgery include patients undergoing mastectomies and patients who have suffered from trauma with significant tissue loss. Tissue flaps have a defined blood supply which originate from the original site of the tissue. The flap can be compromised if the arterial supply or venous drainage is jeopardized during tissue transfer. Therefore, an accurate understanding of the blood supply of the tissue flap is crucial for successful flap reconstructive surgery.

Current pre-operative vascular imaging modalities for flap reconstructive surgery include handheld Doppler ultrasonography, magnetic resonance angiography (MRA), and the gold standard computed tomography angiography (CTA). Doppler ultrasonography is technician-dependent, inaccurate, and lacks optical contrast. MRA is expensive, requires a lengthy imaging time, and requires the administration of intravenous contrast. CTA is also expensive, also requires the administration of intravenous contrast, and requires the administration of ionizing radiation. PACT does not require the administration of intravenous contrast or ionizing radiation, and provides excellent spatial resolution and optical contrast. Therefore, PACT would be an optimal pre-operative vascular imaging modality for flap reconstructive surgery.

Being tested
Photoacoustic Computed Tomography (PACT) Imaging
Keywords
flap reconstructive surgery, Plastic Surgery, Photoacoustic Computed Tomography (PACT)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photoacoustic Computed Tomography (PACT) ImagingDiagnostic test

    PACT will be completed prior surgery.

Study groups in NCT04783272
Study groupRoleWhat they receive
TreatmentExperimentalPhotoacoustic Computed Tomography (PACT) Imaging
Receives: Diagnostic Test: Photoacoustic Computed Tomography (PACT) Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PACT Patient Comfort Questionnaire

    The data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.

    Measured: 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.

  2. Vascular Imaging Modality for Flap Reconstructive Surgery Questionnaire

    The data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start2 Jun 2023
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Why it stopped: Unable to use equipment at partner institution.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04783272
Sponsor's protocol ID
STUDY00000648
Status last verified
Sep 2024
First submitted
17 Feb 2021
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Photoacoustic Computed Tomography (PACT) Imaging in people with Other Reconstructive Surgery and Plastic Surgery, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PACT Patient Comfort Questionnaire (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

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