- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320772
TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
October 24, 2017 updated by: Ding Ma, Huazhong University of Science and Technology
Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer.
Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical Colledge, HUST
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- At least 18 years of age, married, without childbearing requirements at the time of consent.
- FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
- Subject has provided written informed consent.
Exclusion Criteria:
- Breast-feeding or pregnant
- Ongoing participation in another clinical trial with an investigational drug with 3 months
- Own allergy towards ICG and/or alcohol
- Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
- Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TMVP1
The TMVP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL.
0.4ml of TMVP1-ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room.
During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.
|
Detection of SLN
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ACTIVE_COMPARATOR: ICG
The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL.
0.4ml of this ICG solution was injected into the cervix, divided into 3 and 9 o'clock position, in the operating room.
During the laparoscopy, the PinPoint S1 Novadaq (PinPoint Endoscopic Fluorescence Imaging System, NOVADAQ, Mississauga, ON, Canada), 30° laparoscopes were used for fluorescent detection.
|
Detection of SLN
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate of sentinel lymph node
Time Frame: 1 day
|
Detection of sentinel lymph node per patient
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: 7 days
|
7 days
|
|
Sensitivity
Time Frame: 7 days
|
Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
|
7 days
|
Specificity
Time Frame: 7 days
|
Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2017
Primary Completion (ANTICIPATED)
May 1, 2018
Study Completion (ANTICIPATED)
May 1, 2019
Study Registration Dates
First Submitted
October 22, 2017
First Submitted That Met QC Criteria
October 24, 2017
First Posted (ACTUAL)
October 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMVP1-ICG-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on TMVP1-ICG
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Huazhong University of Science and TechnologyUnknownCervical Cancer | Sentinel Lymph NodeChina
-
University of PennsylvaniaCompleted
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Third Affiliated Hospital, Sun Yat-Sen UniversityUnknown
-
Pulsion Medical Systems SEUnknownMalignant Neoplasm of BreastGermany
-
Activ SurgicalRecruitingCholecystitis | Biliary Dyskinesia | CholelithiasisUnited States
-
Huazhong University of Science and TechnologyUnknown
-
Chang Gung Memorial HospitalUnknownFluorenscent Image Guided Surgery | Indocyanide GreenTaiwan
-
National Taiwan University HospitalTaiwanese Osteoposis Association, Wang Jhan-Yang Charitable Trust FundCompletedOsteoporosis FractureTaiwan
-
University of PennsylvaniaCompletedGastric Cancer | Bladder CancerUnited States
-
The First Hospital of QinhuangdaoCompleted