BridgeMD
New treatment option for Needle Biopsy
Official title Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
ClinicalTrials.gov ID: NCT06199492
What this study is testing
- What it's testing
- To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.
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
- Participants must have a primary diagnosis or suspected diagnosis of malignancy and radiographic evidence of malignant lesions involving lymph node...
- A target lesion that meets the following criteria:
- The target lesion must be amenable to image guided biopsy
- The target lesion must be \>= 1cm to ensure that the collected images will have sufficient morphological content to run the OCT image analysis Note...
- Age ≥ 18 years at the time of consenting
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart...
- Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator.
- Absolute neutrophil count \<1000 mm3 within 6 weeks of screening
- Active infection
See the full eligibility criteria
- Participants must have a primary diagnosis or suspected diagnosis of malignancy and radiographic evidence of malignant lesions involving lymph node, liver or lung for which the participant was referred to IR for...
- A target lesion that meets the following criteria:
- The target lesion must be amenable to image guided biopsy
- The target lesion must be \>= 1cm to ensure that the collected images will have sufficient morphological content to run the OCT image analysis Note: The collected biopsy core for the proposed study will undergo H\&E...
- Age ≥ 18 years at the time of consenting
- Life expectancy ≥ 3 months
- Platelet count \>50,000/mm3 within 6 weeks of screening
- INR \<1.5 within 6 weeks of screening
- If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, LMWH preparations)
- ECOG performance status \<= 2 within 6 weeks of screening.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an...
- All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible.
- Ability to understand and the willingness to sign a written informed consent document.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator.
- Absolute neutrophil count \<1000 mm3 within 6 weeks of screening
- Active infection
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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. Enter your location above to see the nearest site and check your eligibility.
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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.