Cervical Intraepithelial NeoplasiaPhase 1NCT03321461
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
A Phase 1 study testing TMTP1 and ICG in people with Cervical Intraepithelial Neoplasia, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- TMTP1 and ICG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to Dec 2021
- 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
- Suspicious of cervical disease required a colposcopy-directed biopsy.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
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.
About this study
Official title: Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- TMTP1, ICG
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMTP1Drug
Fluorescent sites will be removed
ICGDrug
Fluorescent sites will be removed
| Study group | Role | What they receive |
|---|---|---|
| TMTP1 | Experimental | 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. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. Receives: Drug: TMTP1 |
| ICG | Active comparator | The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. Receives: Drug: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
Measured: 1 day
Secondary outcomes (2)
Specificity
Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity 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 Nov 2017
- Primary completion31 Aug 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- NCT03321461
- Sponsor's protocol ID
- TMTP1-ICG-02
- Status last verified
- Jun 2021
- First submitted
- 23 Oct 2017
- Last updated
- 30 Jun 2021
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy
- ClinicalTrials.gov ID
- NCT03321461
- Acronym / sponsor ID
- TMTP1-ICG-02
- Conditions
- Cervical Intraepithelial Neoplasia
- 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 Nov 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- Dec 2021 (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.
Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMTP1 | Experimental | Drug: TMTP1The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. |
| ICG | Active comparator | Drug: ICGThe ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Suspicious of cervical disease required a colposcopy-directed biopsy.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
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 |
|---|---|---|
| TMTP1Fluorescent sites will be removed | Drug | TMTP1 |
| ICGFluorescent sites will be removed | Drug | ICG |
Primary outcome
Sensitivity
Time frame: 1 day
Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG
2 secondary outcomes
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 30 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TMTP1 and ICG in people with Cervical Intraepithelial Neoplasia, 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 2 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 30 Jun 2021. 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?
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?
Sensitivity (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 30 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.