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Tests treatment safety and results for Suspected or Known Squamous Cell Neoplasia
Official title Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
ClinicalTrials.gov ID: NCT06435286
What this study is testing
What is Proflavine Hemisulfate?
Proflavine Hemisulfate is an investigational medicine, being studied as a potential treatment for suspected or known squamous cell neoplasia.
Also referred to as Proflavine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment...
- Patients \>18 years old.
- Patients of any sex or gender.
- Patients who are willing and able to give informed consent.
You likely can't join if
- Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
- Patients who are unable to give informed consent.
- Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in...
- Patient unable to undergo routine endoscopy with biopsy:
- Women who are pregnant or breast feeding,
- Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
See the full eligibility criteria
- Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell...
- Patients \>18 years old.
- Patients of any sex or gender.
- Patients who are willing and able to give informed consent.
- Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
- Patients who are unable to give informed consent.
- Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy.
- Patient unable to undergo routine endoscopy with biopsy:
- Women who are pregnant or breast feeding,
- Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
- Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Barretos, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Barretos, São Paulo, Brazil; São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.