Tongue SCCNCT05424328
Virtual Planning of ALT Flap
A study testing ALTF (Anterolateral thigh flap) with preoperative virtual planning and ALTF (Anterolateral thigh flap) with conventional method in people with Tongue SCC, run by University of Florida.
Trial summary
This study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tongue SCC
- What is being tested?
- ALTF (Anterolateral thigh flap) with preoperative virtual planning and ALTF (Anterolateral thigh flap) with conventional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2025
- 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
- Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy.
- No alveolar ridge involvement by the tumor process.
- Planned to undergo tongue reconstruction using ALTF.
- Patients with a depth of invasion more than 10mm but not crossing midline according to the classification of Ansarin et. al., we perform type IIIA glossectomy.
Who cannot join
- Medically unfit patients; those who are not good candidates for long microvascular surgical reconstructive procedures e.g.: advanced Cardiopulmonary diseases.
- Recurrent tongue carcinoma.
- Patients with lesions invading the alveolar ridge.
- Missing or non-compliance for imaging investigations.
- Patients underwent preoperative adjuvant therapies.
- No children will be involved in this study.
About this study
Official title: Virtual Planning Of Anterolateral Thigh Free Flap for Reconstruction Of Hemiglossectomy
This study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function.
Read the detailed description
This is a prospective randomized clinical study consisting of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method while group B (study group) the Alt flap design and harvest is virtually planned before the operation.
The main issue regarding tongue reconstruction with ALTF is the matching of the size and shape between the harvested flap and the tongue defect assuming the hypothesis that an adequate flap volume is crucial for maintaining tongue function. Meanwhile, the preoperative planning of soft tissues is relatively difficult due to an undefined standardization and reference points. In this study, investigators will evaluate the use of preoperative virtual planning and 3D reconstructions for the restoration of tongue defects with ALTF. In this study, virtual surgical planning for the resection of the tongue cancer (hemi-glossectomy) will be used and will address flap design, which the investigators will base on anatomical landmarks using the preoperative virtual planning technology. The research team will compare the functional ( speech) and cosmetic outcomes of the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction. The null hypothesis of this study is that there is no significant difference in functional \& cosmetic outcome between the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction.
- Conditions
- Tongue SCC
- Being tested
- ALTF (Anterolateral thigh flap) with preoperative virtual planning, ALTF (Anterolateral thigh flap) with conventional method
- Keywords
- SCC, Hemi glossectomy, ALT Flap. virtual planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTF (Anterolateral thigh flap) with preoperative virtual planningProcedure or surgery
In this study group, using preoperative CTs (head \& neck and thigh ) to virtually plan a guide that can be used during the surgery, this guide will determine the design and dimensions of the Alt flap to be harvested and restore the defect left on the tongue due SCC resection and hemi glossectomy.
ALTF (Anterolateral thigh flap) with conventional methodProcedure or surgery
ALTF (Anterolateral thigh flap) will be harvested with conventional method which depends on surgeon's own experience in determining the flap design and dimensions needed to reconstruct and restore the defect left on the tongue due SCC resection and hemi glossectomy.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: ALTF with preoperative virtual planning | Experimental | Subjects will receive ALTF( Anterolateral thigh flap) with preoperative virtual planning Receives: Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planning |
| Control Group: ALTF with conventional method | Active comparator | Subjects will receive ALTF (Anterolateral thigh flap) with conventional method Receives: Procedure: ALTF (Anterolateral thigh flap) with conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy
Investigators will preoperatively use CT measurements and virtual planning 3D software to calculate the required ALT flap volume /cm3 by measuring flap dimensions (height, width and length) /cm3 and compare it with the postoperative real outcomes by re-measuring the real flap dimensions ( height, width and length) /cm3 .
Measured: Changes in flap volume/cm3 will be measured after one and six months after surgery where the preoperative virtually planned volume/cm3 is being the base line.
Secondary outcomes (1)
Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes.
- In the AIDS test the speech analysist examiner will randomly select two sentences (5-15 words) for a total of 22 sentences utilizing table in manual, and reads them aloud once and then allow patients to say them while audio records each session via voice app on phone.
Judge from the investigators will listen and transcribe. Making a report and develop outcomes.
- Scoring will be according the standard scores of the AIDS test analysis where:
- Intelligibility: Corresponds to number of correct words.
- Speaking rate: Corresponds to words per minute (WPM) / duration of sentence samples in minutes
- Rate of intelligible speech (intelligible words per minute (IWPM)): number of words identified correctly /total duration
- Rate of unintelligible (unintelligible words per minute (UWPM)): number of unintelligible/total duration
- Communication efficiency ratio: IWPM/190 IWPM.
Measured: Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Fellow left UF study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tongue SCCStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consists of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method where flap design and volume depends on surgeon's own experience while group B (study group) the Alt flap design and volume will be harvested by the aid of a guide that is virtually planned before the operation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Fernandes, MD, DMD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424328
- Sponsor's protocol ID
- IRB202201118
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Planning Of Anterolateral Thigh Free Flap for Reconstruction Of Hemiglossectomy
- ClinicalTrials.gov ID
- NCT05424328
- Acronym / sponsor ID
- IRB202201118
- Conditions
- Tongue SCC
- Keywords
- SCC, Hemi glossectomy, ALT Flap. virtual planning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Fellow left UF study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Jun 2022 (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 study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function.
Detailed description
This is a prospective randomized clinical study consisting of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method while group B (study group) the Alt flap design and harvest is virtually planned before the operation.
The main issue regarding tongue reconstruction with ALTF is the matching of the size and shape between the harvested flap and the tongue defect assuming the hypothesis that an adequate flap volume is crucial for maintaining tongue function. Meanwhile, the preoperative planning of soft tissues is relatively difficult due to an undefined standardization and reference points. In this study, investigators will evaluate the use of preoperative virtual planning and 3D reconstructions for the restoration of tongue defects with ALTF. In this study, virtual surgical planning for the resection of the tongue cancer (hemi-glossectomy) will be used and will address flap design, which the investigators will base on anatomical landmarks using the preoperative virtual planning technology. The research team will compare the functional ( speech) and cosmetic outcomes of the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction. The null hypothesis of this study is that there is no significant difference in functional \& cosmetic outcome between the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method where flap design and volume depends on surgeon's own experience while group B (study group) the Alt flap design and volume will be harvested by the aid of a guide that is virtually planned before the operation.
| Arm | Type | Receives |
|---|---|---|
| Study Group: ALTF with preoperative virtual planning | Experimental | Procedure: ALTF (Anterolateral thigh flap) with preoperative virtual planningSubjects will receive ALTF( Anterolateral thigh flap) with preoperative virtual planning |
| Control Group: ALTF with conventional method | Active comparator | Procedure: ALTF (Anterolateral thigh flap) with conventional methodSubjects will receive ALTF (Anterolateral thigh flap) with conventional method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy.
- No alveolar ridge involvement by the tumor process.
- Planned to undergo tongue reconstruction using ALTF.
- Patients with a depth of invasion more than 10mm but not crossing midline according to the classification of Ansarin et. al., we perform type IIIA glossectomy.
Key exclusion criteria (6 listed)
- Medically unfit patients; those who are not good candidates for long microvascular surgical reconstructive procedures e.g.: advanced Cardiopulmonary diseases.
- Recurrent tongue carcinoma.
- Patients with lesions invading the alveolar ridge.
- Missing or non-compliance for imaging investigations.
- Patients underwent preoperative adjuvant therapies.
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 |
|---|---|---|
| ALTF (Anterolateral thigh flap) with preoperative virtual planningIn this study group, using preoperative CTs (head \& neck and thigh ) to virtually plan a guide that can be used during the surgery, this guide will determine the design and dimensions of the Alt flap to be harvested and restore the defect left on the tongue due SCC resection and hemi glossectomy. | Procedure or surgery | Study Group: ALTF with preoperative virtual planning |
| ALTF (Anterolateral thigh flap) with conventional methodALTF (Anterolateral thigh flap) will be harvested with conventional method which depends on surgeon's own experience in determining the flap design and dimensions needed to reconstruct and restore the defect left on the tongue due SCC resection and hemi glossectomy. | Procedure or surgery | Control Group: ALTF with conventional method |
Primary outcome
Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy
Time frame: Changes in flap volume/cm3 will be measured after one and six months after surgery where the preoperative virtually planned volume/cm3 is being the base line.
Investigators will preoperatively use CT measurements and virtual planning 3D software to calculate the required ALT flap volume /cm3 by measuring flap dimensions (height, width and length) /cm3 and compare it with the postoperative real outcomes by re-measuring the real flap dimensions ( height, width and length) /cm3 .
1 secondary outcome
Assessment of Intelligibility of Dysarthric Speech (AIDS) test will be used to assess tongue speech functions following tongue reconstruction and compare speech changes.
Time frame: Changes of speech will be compared After one and six months after surgery where the preoperative speech will be the base line.
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 24 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Rui Fernandes, MD, DMD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing ALTF (Anterolateral thigh flap) with preoperative virtual planning and ALTF (Anterolateral thigh flap) with conventional method in people with Tongue SCC, run by University of Florida.
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 6 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Prospectively evaluate a new method of virtually planned ALTF and changes in flap volume for the reconstruction of tongue defects following hemi-glossectomy (time frame: Changes in flap volume/cm3 will be measured after one and six months after surgery where the preoperative virtually planned volume/cm3 is being the base line.). 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 24 Jun 2024.