Mammoplasty PatientNCT04063410
Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy
A study testing Angiography, MRI-Based Angiogram and Quality-of-Life Assessment in people with Mammoplasty Patient, run by University of Cincinnati at 1 site in United States.
Trial summary
This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mammoplasty Patient
- What is being tested?
- Angiography, MRI-Based Angiogram and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must weigh =< 350 lbs.
- Subject must be scheduled to receive uni- or bilateral breast reconstruction using one of the abdominal-based free flap techniques (deep inferior epigastric perforator [DIEP] flap, superficial inferior epigastric artery [SIEA] flap, or free-transverse rectus abdominis musculocutaneous [TRAM] flap) within the next 12 months.
- Subject must have received, or be scheduled to receive at least one preoperative CTA prior to the surgery.
- Subject must be able to lie in both prone and supine positions for at least 30 minutes.
Who cannot join
- Subjects who are determined to be incompatible for MRI based on local policy.
- Subjects with previous history of abdominal-based free flap surgery.
- Severe anxiety or claustrophobia that would prohibit the required study procedures from being conducted.
- Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with the subject?s safety, the informed consent procedure, or compliance to the study protocol, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Single-Institution, Single-Arm, Self-Controlled Trial Evaluating Perforator Phase Contrast Angiography (pPCA) as the Primary Preoperative Imaging Technique in Post-Mastectomy Breast Reconstruction Using Abdominal-Based Free Flaps
This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the quality of surgical plans prepared under the guidance of the non-contrast, ionizing-radiation-free perforator phase contrast angiography (pPCA) against plans based upon the current gold standard, the X-ray-based, contrast-enhanced computed tomographic angiography (CTA).
SECONDARY OBJECTIVES:
- To assess whether pPCA is more accurate than CTA for vessel size measurement.
II. To assess the impact of pPCA-based surgical planning on the clinical outcomes of abdominal-based free flap surgery.
III. To obtain and analyze cost/expenditure information for pPCA-guided abdominal-based free flap procedures.
OUTLINE:
Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.
After surgery, patients will be followed up at 24 hours, 1 week, 3 months, 1 year and 2 years.
- Conditions
- Mammoplasty Patient
- Being tested
- Angiography, MRI-Based Angiogram, Quality-of-Life Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngiographyProcedure or surgery
Undergo standard of care CTA
MRI-Based AngiogramProcedure or surgery
Also called Magnetic Resonance Angiogram, MRA
Undergo pPCA
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening (pPCA) | Experimental | Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery. Receives: Procedure: Angiography; Procedure: MRI-Based Angiogram; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of surgical plan scenarios
When all participating plastic surgeons reach a consensus decision on the final surgical plan after jointly reviewing the perforator phase contrast angiography (pPCA)-based and contrast-enhanced computed (CTA) based preliminary plans, one of four scenarios may occur: I. The pPCA-based and CTA-based plans are identical. Both are accepted as the final plan; II. There is substantial discrepancy between the two preliminary plans. The pPCA-based plan is eventually accepted as the final plan; III. There is substantial discrepancy between the two preliminary plans. The CTA-based plan is eventually accepted as the final plan; IV. There is substantial discrepancy between the two preliminary plans, but neither the pPCA-based plan nor the CTA-based plan is deemed acceptable. The final plan is proposed based upon comprehensive assessment of both image sets. The occurrence rate of scenario I-IV cases will be estimated with 95% confidence interval, respectively.
Measured: Up to 2 years
Acceptance rate for pPCA-based surgical plans
The acceptance rate for pPCA-based plans will be evaluated using one-sided non-inferiority test of correlated proportions with non-inferiority margin of 15%. Perforator size measurements obtained with pPCA or CTA will be summarized separately, and be compared between pPCA and CTA using paired t-test.
Measured: Up to 2 years
Postoperative major complication rate
Will be calculated and exact binomial 95% confidence interval will be provided. The calculated major complication rate will be compared with historical data. The association of complications with demographic and clinical characteristics (e.g., age, obesity, laterality and radiation) will be explored using two sample t-test or Wilcoxon test for continuous variables, and chi-square test or Fisher?s exact test for categorical variables. Logistic regression model will also be used to study the association between the complications and the pPCA/CTA-based plans, controlling those significant confounders.
Measured: At 2 years
Quality of life questionnaire (BREAST-Q)
Patient reported outcome for breast reconstruction questionnaire (BREAST-Q) score for satisfaction with breast will be summarized using descriptive statistics (mean and standard deviation) at baseline, 1 year postoperative, 2 years postoperative, as well as the change from baseline to postoperative. BREAST-Q score at 2 years will be compared with historical data.
Measured: Baseline up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: We are closing this study as our clinical partners have all relocate from OSU and we could not find continued interest. However, we demonstrated the feasibility of this imaging approach on which we also filed a patent.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammoplasty PatientStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael Knopp, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063410
- Sponsor's protocol ID
- OSU-18094
- Other IDs
- NCI-2018-03417
- Status last verified
- Jan 2024
- First submitted
- 19 Aug 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Institution, Single-Arm, Self-Controlled Trial Evaluating Perforator Phase Contrast Angiography (pPCA) as the Primary Preoperative Imaging Technique in Post-Mastectomy Breast Reconstruction Using Abdominal-Based Free Flaps
- ClinicalTrials.gov ID
- NCT04063410
- Acronym / sponsor ID
- OSU-18094
- Conditions
- Mammoplasty Patient
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We are closing this study as our clinical partners have all relocate from OSU and we could not find continued interest. However, we demonstrated the feasibility of this imaging approach on which we also filed a patent.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Aug 2019 (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.
This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal (mastectomy) using abdominal-based free flap methods. Free flaps are units of tissue transferred from one area of the body to another with an intact blood supply. pPCA uses magnetic resonance imaging (MRI) to create images of blood vessels inside the body. Using pPCA may help doctors develop better surgical plans for patients with breast cancer undergoing post-mastectomy reconstruction surgery with free flap methods.
Detailed description
PRIMARY OBJECTIVES:
- To assess the quality of surgical plans prepared under the guidance of the non-contrast, ionizing-radiation-free perforator phase contrast angiography (pPCA) against plans based upon the current gold standard, the X-ray-based, contrast-enhanced computed tomographic angiography (CTA).
SECONDARY OBJECTIVES:
- To assess whether pPCA is more accurate than CTA for vessel size measurement.
II. To assess the impact of pPCA-based surgical planning on the clinical outcomes of abdominal-based free flap surgery.
III. To obtain and analyze cost/expenditure information for pPCA-guided abdominal-based free flap procedures.
OUTLINE:
Patients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery.
After surgery, patients will be followed up at 24 hours, 1 week, 3 months, 1 year and 2 years.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (pPCA) | Experimental | Procedure: Angiography, Procedure: MRI-Based Angiogram, Other: Quality-of-Life AssessmentPatients undergo standard of care CTA and undergo pPCA MRI for up to 60 minutes before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must weigh =< 350 lbs.
- Subject must be scheduled to receive uni- or bilateral breast reconstruction using one of the abdominal-based free flap techniques (deep inferior epigastric perforator [DIEP] flap, superficial inferior epigastric artery [SIEA] flap, or free-transverse rectus abdominis musculocutaneous [TRAM] flap) within the next 12 months.
- Subject must have received, or be scheduled to receive at least one preoperative CTA prior to the surgery.
- Subject must be able to lie in both prone and supine positions for at least 30 minutes.
Key exclusion criteria (4 listed)
- Subjects who are determined to be incompatible for MRI based on local policy.
- Subjects with previous history of abdominal-based free flap surgery.
- Severe anxiety or claustrophobia that would prohibit the required study procedures from being conducted.
- Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with the subject?s safety, the informed consent procedure, or compliance to the study protocol, in the opinion of the investigator.
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 |
|---|---|---|
| AngiographyUndergo standard of care CTA | Procedure or surgery | Screening (pPCA) |
| MRI-Based AngiogramAlso: Magnetic Resonance Angiogram, MRAUndergo pPCA | Procedure or surgery | Screening (pPCA) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Screening (pPCA) |
Primary outcome
Occurrence rate of surgical plan scenarios
Time frame: Up to 2 years
When all participating plastic surgeons reach a consensus decision on the final surgical plan after jointly reviewing the perforator phase contrast angiography (pPCA)-based and contrast-enhanced computed (CTA) based preliminary plans, one of four scenarios may occur: I. The pPCA-based and CTA-based plans are identical. Both are accepted as the final plan; II. There is substantial discrepancy between the two preliminary plans. The pPCA-based plan is eventually accepted as the final plan; III. There is substantial discrepancy between the two preliminary plans. The CTA-based plan is eventually accepted as the final plan; IV. There is substantial discrepancy between the two preliminary plans, but neither the pPCA-based plan nor the CTA-based plan is deemed acceptable. The final plan is proposed based upon comprehensive assessment of both image sets. The occurrence rate of scenario I-IV cases will be estimated with 95% confidence interval, respectively.
Acceptance rate for pPCA-based surgical plans
Time frame: Up to 2 years
The acceptance rate for pPCA-based plans will be evaluated using one-sided non-inferiority test of correlated proportions with non-inferiority margin of 15%. Perforator size measurements obtained with pPCA or CTA will be summarized separately, and be compared between pPCA and CTA using paired t-test.
Postoperative major complication rate
Time frame: At 2 years
Will be calculated and exact binomial 95% confidence interval will be provided. The calculated major complication rate will be compared with historical data. The association of complications with demographic and clinical characteristics (e.g., age, obesity, laterality and radiation) will be explored using two sample t-test or Wilcoxon test for continuous variables, and chi-square test or Fisher?s exact test for categorical variables. Logistic regression model will also be used to study the association between the complications and the pPCA/CTA-based plans, controlling those significant confounders.
Quality of life questionnaire (BREAST-Q)
Time frame: Baseline up to 2 years
Patient reported outcome for breast reconstruction questionnaire (BREAST-Q) score for satisfaction with breast will be summarized using descriptive statistics (mean and standard deviation) at baseline, 1 year postoperative, 2 years postoperative, as well as the change from baseline to postoperative. BREAST-Q score at 2 years will be compared with historical data.
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 18 Jan 2024.
- The JameslineLink provided by the sponsor.
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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.
Michael Knopp, MD principal investigator
Ohio State University Comprehensive Cancer 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 Angiography, MRI-Based Angiogram and Quality-of-Life Assessment in people with Mammoplasty Patient, run by University of Cincinnati 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 4 inclusion and 4 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 18 Jan 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?
Occurrence rate of surgical plan scenarios (time frame: Up to 2 years). The study lists 4 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 18 Jan 2024.