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.
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
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.
- Conditions
- Other Reconstructive Surgery, Plastic 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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Photoacoustic 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.
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.
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.
- First posted5 Mar 2021
- Study start2 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Why it stopped: Unable to use equipment at partner institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Reconstructive SurgeryStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Ray, Cedars-Sinai Medical Center
- Investigators
- Edward Ray, MD, Principal investigator, Cedars-Sinai Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography - Pilot Study
- ClinicalTrials.gov ID
- NCT04783272
- Acronym / sponsor ID
- STUDY00000648
- Conditions
- Other Reconstructive Surgery, Plastic Surgery
- Keywords
- flap reconstructive surgery, Plastic Surgery, Photoacoustic Computed Tomography (PACT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to use equipment at partner institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Diagnostic Test: Photoacoustic Computed Tomography (PACT) ImagingPhotoacoustic Computed Tomography (PACT) Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic Computed Tomography (PACT) ImagingPACT will be completed prior surgery. | Diagnostic test | Treatment |
Primary outcome
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 data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.
Vascular Imaging Modality for Flap Reconstructive Surgery Questionnaire
Time frame: This questionnaire will be completed by Dr. Edward Ray immediately following surgery.
The data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Ray, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
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.