Breast ReconstructionNCT03949491
Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
A study testing 3D medical models in people with Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- 3D medical models
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 1 Aug 2022
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
- Performance statusECOG Performance status ≤ 2
- Subjects must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 10.0 g/dl
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
Show all 12Show fewer
- Platelet count ≥ 100,000/mcL
- Total bilirubin within normal institutional limits
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
- Serum Creatinine within normal institutional limits
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
- Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
Read the detailed description
Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.
Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.
This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction
- Conditions
- Breast Reconstruction
- Being tested
- 3D medical models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D medical modelsProcedure or surgery
Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease both operative time and dissection time. This will also allow for the proposal of incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes, decrease donor site complications and improve patient satisfaction
| Study group | Role | What they receive |
|---|---|---|
| 3-D virtual planning and medical modeling of breast | Experimental | 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction.
* Preoperative CT-Angiogram of the abdominal wall
* Volumetric analysis preformed
* 3D printed models made
* Pre operative BREAST-Questionnaires given
* Free tissue transfer performed: Operative/Dissection Time Recorded
* Flap/Abdominal donor site complications recorded
* Standard Digital Photography and Harris Scoring
* BREAST-Questionnaires given at 3, 6 months Receives: Procedure: 3D medical models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative time
Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Measured: Up to 6 months after reconstruction
Mean dissection time
Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Measured: Up to 6 months after reconstruction
Secondary outcomes (4)
Aesthetic outcomes as measured by the Harris scale
Aesthetic outcomes as measured by the Harris scale, which ranges from 1-4, with higher scores indicating worse outcomes.
Measured: Up to 1 year after reconstruction
Donor site complications
Number of donor site complications will be reported
Measured: Up to 1 year after reconstruction
Incidence of fat necrosis as measured by a grading system
Incidence of fat necrosis will be measured in the postoperative period using a classification system. Grade I necrosis will be defined as minimal requiring no surgical intervention; Grade II necrosis will be minor with some aesthetic defect requiring primary excision and closure; Grade III necrosis will be defined as requiring secondary procedures after excision to achieve satisfactory cosmesis; Grade IV necrosis will involve a necrosectomy requiring a either a completely new flap or at least a second flap to address such problems; Grade V necrosis will be defined as complete flap failure 5.
Higher grade of fat necrosis is worse.
Measured: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.
Patient satisfaction as measured by BREAST-Q scores
Patient satisfaction as measured by BREAST-Q scores which ranges from 4-16, with higher scores indicating more satisfaction with breasts.
Measured: Up to 1 year after reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Dec 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Principal Investigator left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Ghaznavi, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949491
- Sponsor's protocol ID
- CASE6118
- Status last verified
- Feb 2024
- First submitted
- 30 Apr 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling
- ClinicalTrials.gov ID
- NCT03949491
- Acronym / sponsor ID
- CASE6118
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the institution.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 14 May 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.
The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.
Detailed description
Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.
Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.
This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-D virtual planning and medical modeling of breast | Experimental | Procedure: 3D medical models3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction. * Preoperative CT-Angiogram of the abdominal wall * Volumetric analysis preformed * 3D printed models made * Pre operative BREAST-Questionnaires given * Free tissue transfer performed: Operative/Dissection Time Recorded * Flap/Abdominal donor site complications recorded * Standard Digital Photography and Harris Scoring * BREAST-Questionnaires given at 3, 6 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
- Performance statusECOG Performance status ≤ 2
- Subjects must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 10.0 g/dl
- Leukocytes ≥ 3,000/mcL
Key exclusion criteria (4 listed)
- Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
- Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.
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 |
|---|---|---|
| 3D medical modelsUsing 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease both operative time and dissection time. This will also allow for the proposal of incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes, decrease donor site complications and improve patient satisfaction | Procedure or surgery | 3-D virtual planning and medical modeling of breast |
Primary outcome
Mean operative time
Time frame: Up to 6 months after reconstruction
Mean operative time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
Mean dissection time
Time frame: Up to 6 months after reconstruction
Mean dissection time using 3D medical models of the abdomen to create a virtual plan to assist reconstruction.
4 secondary outcomes
Aesthetic outcomes as measured by the Harris scale
Time frame: Up to 1 year after reconstruction
Donor site complications
Time frame: Up to 1 year after reconstruction
Incidence of fat necrosis as measured by a grading system
Time frame: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post reconstruction.
Patient satisfaction as measured by BREAST-Q scores
Time frame: Up to 1 year after reconstruction
Results and safety
The study was stopped early (reason given: Principal Investigator left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in publication
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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.
Amir Ghaznavi principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D medical models in people with Breast Reconstruction, run by Case Comprehensive Cancer 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 12 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: stopped early, as of the sponsor's last update on 7 Feb 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 stopped early (reason given: Principal Investigator left the institution.). Results are not available in the source record.
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?
Mean operative time (time frame: Up to 6 months after reconstruction). 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 7 Feb 2024.