Cervical CancerPhase 1NCT03320772
TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
A Phase 1 study testing TMVP1-ICG and ICG in people with Cervical Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- TMVP1-ICG and ICG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to May 2019
- Phase
- Phase 1
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical Colledge, HUST
Wuhan, Hubei, 430030
Juncheng Wei, Dr., 027-83663351, wjcwjc999@126.com
About this study
Official title: 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.
- Conditions
- Cervical Cancer
- Being tested
- TMVP1-ICG, ICG
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMVP1-ICGDrug
Detection of SLN
ICGDrug
Detection of SLN
| Study group | Role | What they receive |
|---|---|---|
| TMVP1 | Experimental | 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. Receives: Drug: TMVP1-ICG |
| ICG | Active comparator | 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. Receives: Drug: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of sentinel lymph node
Detection of sentinel lymph node per patient
Measured: 1 day
Secondary outcomes (3)
Sensitivity
Sensitivity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Measured: 7 days
Specificity
Specificity of SLN mapping of TMVP1-ICG compared to the sensitivity of SLN mapping of ICG
Measured: 7 days
Incidence of adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 May 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320772
- Sponsor's protocol ID
- TMVP1-ICG-01
- Status last verified
- Oct 2017
- First submitted
- 22 Oct 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT03320772
- Acronym / sponsor ID
- TMVP1-ICG-01
- Conditions
- Cervical Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 25 Oct 2017 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMVP1 | Experimental | Drug: TMVP1-ICGThe 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. |
| ICG | Active comparator | Drug: ICGThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| TMVP1-ICGDetection of SLN | Drug | TMVP1 |
| ICGDetection of SLN | Drug | ICG |
Primary outcome
Detection rate of sentinel lymph node
Time frame: 1 day
Detection of sentinel lymph node per patient
3 secondary outcomes
Sensitivity
Time frame: 7 days
Specificity
Time frame: 7 days
Incidence of adverse events
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMVP1-ICG and ICG in people with Cervical Cancer, run by Huazhong University of Science and Technology at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Oct 2017. 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 China. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danhui Weng, Dr. (027-83663351, weng.dh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of sentinel lymph node (time frame: 1 day). 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 25 Oct 2017.