Dermatofibrosarcoma Protuberans (DFSP)Phase 1NIFR;SWIGNCT06610071
NIFR Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose SWIG Technique
A Phase 1 study testing ICG administration in people with Dermatofibrosarcoma Protuberans (DFSP) and Skin Squamous Cell Carcinoma, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Trial summary
This research study will evaluate how near-infrared fluorescence (NIRF) imaging with low-dose second window indocyanine green (ICG) can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma, such as dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dermatofibrosarcoma Protuberans (DFSP), Skin Squamous Cell Carcinoma
- What is being tested?
- ICG administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with DFSPs or sSCC in heads, extremities or trunk
Who cannot join
- seafood/iodine allergy
- hyperthyroidism
- pregnancy
- myasthenia gravis
- acute severe hypertension
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique: a Multicenter Randomized Controlled Trial
This research study will evaluate how near-infrared fluorescence (NIRF) imaging with low-dose second window indocyanine green (ICG) can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma, such as dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC) during surgery.
Read the detailed description
To improve the accuracy of radical resection by reducing the risk of missed diagnosis of positive margin, this study will explore clinical application of near-infrared fluorescence imaging with modified low-dose SWIG technique in guiding radical resection of malignant soft tissue tumor. The investigators conduct a multi-center, multi-subgroup, prospective randomized controlled trial. The participants will be first stratified according to histological type involving dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC). The patients with DFSP or sSCC will be then randomly assigned to three groups. Patients in the control group will not receive ICG administration. The ICG was injected intravenously 24 hours before surgery, at a dose of 0.25 mg/kg in the first experimental group and 25 mg/patient in the second experimental group, respectively. The patients in the control groups will undergo traditional assessment of surgical margins.The patients in the experimental groups, on the other hand, will be scheduled to intraoperative near-infrared fluorescence imaging to scan gross tumor, tumor bed and cross-sectional specimen. The 2-year local recurrence rate will be regarded as primary outcome. The number of positive margins will be compared among groups. The investigators will also calculate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals based on fluorescent signal of tumor bed in the experimental groups.
- Being tested
- ICG administration
- Keywords
- near-infrared fluorescence imaging, second window indocyanine green, dermatofibrosarcoma protuberans, skin squamous cell carcinoma
- Medical subject headings
- Dermatofibrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG administrationDrug
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group.
ICG administrationDrug
The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
ICG administrationDrug
The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group
ICG administrationDrug
The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DFSP in the first experimental group | Experimental | The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group. Receives: Drug: ICG administration |
| Patients with DFSP in the second experimental group | Experimental | The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. Receives: Drug: ICG administration |
| Patients with DFSP in the control group | No intervention | Not described |
| Patients with sSCC in the first experimental group | Experimental | The ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group. Receives: Drug: ICG administration |
| Patients with sSCC in the second experimental group | Experimental | The ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. Receives: Drug: ICG administration |
| Patients with sSCC in the control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year local recurrence rate
Measured: up to 24 months
Secondary outcomes (3)
number of positive margins
Measured: through study completion, an average of 2 years
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Measured: through study completion, an average of 2 years
Adverse effects
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start30 Oct 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatofibrosarcoma Protuberans (DFSP)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese PLA General Hospital, Peking University International Hospital
- Responsible party
- Principal investigator, Lei Cui, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610071
- Sponsor's protocol ID
- CFH2024-2-4043
- Acronym
- NIFR;SWIG
- Status last verified
- Sep 2024
- First submitted
- 1 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will include patient characteristics, tumor location, tumor size and histological type and grade. The number of positive margins will be recorded. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will also be calculated. The adverse effects between first and second experimental groups will be compared. The 2-year local recurrence rate will be viewed as primary outcome.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Fluorescence Image-guided Surgery for Malignant Soft Tissue Tumor With Low-dose Second Window Indocyanine Green Technique: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06610071
- Acronym / sponsor ID
- NIFR;SWIG / CFH2024-2-4043
- Keywords
- near-infrared fluorescence imaging, second window indocyanine green, dermatofibrosarcoma protuberans, skin squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Chinese PLA General Hospital, Peking University International Hospital
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Sep 2024 (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 research study will evaluate how near-infrared fluorescence (NIRF) imaging with low-dose second window indocyanine green (ICG) can assist in the radical resection and pathologic diagnosis of malignant soft tissue sarcoma, such as dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC) during surgery.
Detailed description
To improve the accuracy of radical resection by reducing the risk of missed diagnosis of positive margin, this study will explore clinical application of near-infrared fluorescence imaging with modified low-dose SWIG technique in guiding radical resection of malignant soft tissue tumor. The investigators conduct a multi-center, multi-subgroup, prospective randomized controlled trial. The participants will be first stratified according to histological type involving dermatofibrosarcoma protuberans (DFSP) and skin squamous cell carcinoma (sSCC). The patients with DFSP or sSCC will be then randomly assigned to three groups. Patients in the control group will not receive ICG administration. The ICG was injected intravenously 24 hours before surgery, at a dose of 0.25 mg/kg in the first experimental group and 25 mg/patient in the second experimental group, respectively. The patients in the control groups will undergo traditional assessment of surgical margins.The patients in the experimental groups, on the other hand, will be scheduled to intraoperative near-infrared fluorescence imaging to scan gross tumor, tumor bed and cross-sectional specimen. The 2-year local recurrence rate will be regarded as primary outcome. The number of positive margins will be compared among groups. The investigators will also calculate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) with 95% confidence intervals based on fluorescent signal of tumor bed in the experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with DFSP in the first experimental group | Experimental | Drug: ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group. |
| Patients with DFSP in the second experimental group | Experimental | Drug: ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. |
| Patients with DFSP in the control group | No intervention | – |
| Patients with sSCC in the first experimental group | Experimental | Drug: ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group. |
| Patients with sSCC in the second experimental group | Experimental | Drug: ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. |
| Patients with sSCC in the control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with DFSPs or sSCC in heads, extremities or trunk
Key exclusion criteria (5 listed)
- seafood/iodine allergy
- hyperthyroidism
- pregnancy
- myasthenia gravis
- acute severe hypertension
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 |
|---|---|---|
| ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group. | Drug | Patients with DFSP in the first experimental group |
| ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. | Drug | Patients with DFSP in the second experimental group |
| ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 0.25 mg/kg in the first experimental group | Drug | Patients with sSCC in the first experimental group |
| ICG administrationThe ICG was injected intravenously 24 hours before surgery at a dose of 25 mg/patient in the second experimental group. | Drug | Patients with sSCC in the second experimental group |
Primary outcome
2-year local recurrence rate
Time frame: up to 24 months
3 secondary outcomes
number of positive margins
Time frame: through study completion, an average of 2 years
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)
Time frame: through study completion, an average of 2 years
Adverse effects
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The IPD will include patient characteristics, tumor location, tumor size and histological type and grade. The number of positive margins will be recorded. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will also be calculated. The adverse effects between first and second experimental groups will be compared. The 2-year local recurrence rate will be viewed as primary outcome.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICG administration in people with Dermatofibrosarcoma Protuberans (DFSP) and Skin Squamous Cell Carcinoma, run by The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
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 5 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: opening soon, as of the sponsor's last update on 24 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Han (+86-15001222456, hanyudi_301@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year local recurrence rate (time frame: up to 24 months). 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 Sep 2024.