A Phase 1 interventional study of TMTP1-ICG and ICG in Cervical Cancer, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Huazhong University of Science and Technology · Phase 1, Interventional, and Diagnostic
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Among 16 studies in Uterine Cervical Neoplasms by Huazhong University of Science and Technology — 1 open to participants now, 4 under way, 2 of them phase 3. Uterine Cervical Neoplasms · Huazhong University of Science and Technology.
Among the 16 studies in Uterine Cervical Neoplasms by Huazhong University of Science and Technology, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2017, is one of 3 in phase 1, and was the 10th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →1 of the 16 studies in Uterine Cervical Neoplasms by Huazhong University of Science and Technology is open now, in 1 country. Recruiting first, the newest first:
Huazhong University of Science and Technology · Sites in China
Ages 18–70 · Women only
By country, each count listing its studies:
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 60 Years · female · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 253 across the 10 interventional studies, 6,600 across the 6 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Uterine Cervical Neoplasms by Huazhong University of Science and Technology, from their registry updates:
Nothing recorded among them since 2026-09-25.
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investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping
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Exclusion Criteria:
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The TMTP1-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 this TMTP1-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.
Drug: TMTP1-ICG
The ICG powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. 0.4ml of 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.
Drug: ICG
Detection of SLN
Detection of SLN
Detection rate of sentinel lymph node
Detection of sentinel lymph node per patient
Time frame: 1 day
Sensitivity
Sensitivity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG
Time frame: 7 days
Specificity
Specificity of SLN mapping of TMTP1-ICG compared to the sensitivity of SLN mapping of ICG
Time frame: 7 days
Incidence of adverse events
Time frame: 7 days
Started Sep 2017 (actual). Primary completion is estimated for Sep 2018, 12 months after the start.
Of 58 non-industry phase 1 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 72. This study's planned 12 months is below that.
Counting every sponsor, half of 142 studies reached it within 48 months; a quarter within 27 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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