Imaging Device for Needle Biopsy

Overseen By Rahul A Sheth, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Active infection, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging device called tVisio-1 to determine if it can spot tumor tissue before doctors perform a biopsy (a small tissue sample). The device uses a special imaging technique to capture pictures through the biopsy needle, potentially identifying tumors more accurately. Suitable participants have a confirmed or suspected cancer diagnosis with noticeable lesions in areas such as the lymph nodes, liver, or lungs that require a biopsy. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cancer diagnosis techniques.

Will I have to stop taking my current medications?

If you are taking antiplatelet or anticoagulation medications, you may need to stop them 48 hours before the procedure, unless the study doctor decides otherwise. Other medications, including standard chemotherapy, immunotherapy, or targeted therapy, are allowed.

What prior data suggests that this imaging device is safe for identifying tumor tissue?

Studies have shown that imaging devices used in biopsies are generally safe and well-tolerated. The tVisio-1 device captures images of tissue during a biopsy. It fits into the standard biopsy needle and employs a special imaging method called optical coherence tomography (OCT).

Although specific safety data for tVisio-1 is not available, similar biopsy devices have been used safely. These devices are designed to prevent harm and contamination, ensuring the safety of both patients and healthcare workers.

The tVisio-1 device is neither a drug nor an invasive treatment. It assists doctors in seeing tissue more clearly before taking samples, aiming to improve the biopsy process without adding risks. Overall, similar technologies have been used effectively and safely in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tVisio-1 imaging device because it offers a new way to enhance needle biopsy procedures. Unlike traditional biopsies, which rely solely on physical samples, tVisio-1 uses optical coherence tomography (OCT) to capture detailed images of the tissue before collecting samples. This innovative approach aims to improve the accuracy of identifying tumor tissue, potentially leading to better diagnosis and treatment decisions. By integrating advanced imaging directly into the biopsy process, tVisio-1 could significantly reduce the chances of missing critical tumor areas.

What evidence suggests that this imaging device is effective for identifying tumor tissue before a biopsy?

Research shows that the tVisio-1 device, used by participants in this trial, employs optical coherence tomography (OCT) to identify tumors before a biopsy. OCT creates detailed images of tissue, aiding in tumor detection. Studies have shown that OCT can capture clear, detailed pictures of tissues. This technology has been tested on various tissues, including the thyroid, demonstrating its potential to guide biopsies more accurately. Using OCT may simplify the process of locating and sampling tumor tissue, enhancing biopsy precision. ^{6 7 8 9 10}

Who Is on the Research Team?

Rahul A Sheth, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a primary or suspected diagnosis of cancer, specifically in the lymph node, liver, or lung. They should have lesions suitable for biopsy and be able to stop blood-thinning medications before the procedure. People can't join if they're pregnant/nursing without contraception, have severe illnesses that could affect participation, or an active infection.

Inclusion Criteria

Platelet count >50,000/mm3 within 6 weeks of screening

Life expectancy ≥ 3 months

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Absolute neutrophil count <1000 mm3 within 6 weeks of screening

I am not pregnant or nursing, and if capable of becoming pregnant, I am using effective birth control.

I do not have any severe illnesses or conditions that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo OCT imaging to identify tumor tissue before biopsy, followed by the collection of biopsy cores

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• tVisio-1

Trial Overview The study is testing tVisio-1, an investigational imaging device designed to detect tumor tissue more accurately during needle biopsy procedures on patients with certain types of malignant lesions.

How Is the Trial Designed?

Group I: tVisio-1 Experimental Treatment 1 Intervention

The device collects optical coherence tomography (OCT) images in an effort to identify tumor tissue before physical samples are collected. During the biopsy, a sterilized optical imaging probe will be placed through the standard biopsy guidance needle to collect a few images of the tissue at the tip of the biopsy needle. Then the regular biopsy will continue to collect a few biopsy cores.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 192 patients undergoing endoscopic ultrasound-guided tissue acquisition (EUS-TA) for pancreatic lesions, hypervascular tumors and liver cirrhosis were identified as significant risk factors for adverse events, with odds ratios of 4.96 and 5.3, respectively.

The use of Franseen-tip needles did not increase the risk of adverse events compared to conventional FNA or FNB needles, suggesting that these newer needles are as safe as traditional options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. Lin, YC., Yen, HH., Huang, SP., et al.[2022]

The new 'Fourier' driver technique allows for precise placement of biopsy needles and treatment electrodes in abnormal tissues, enhancing accuracy and reducing trauma during procedures, regardless of the lesion's hardness or elasticity.

This technique can be combined with a computer-controlled anti-seeding system to minimize the risk of spreading viable tumor cells during the biopsy process, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new method to gently place biopsy needles or treatment electrodes into tissues with high target precision. Wiksell, H., Löfgren, L., Schässburger, KU., et al.[2017]

In a study of 100 consecutive biopsies using a specialized 18-gauge needle, a specific diagnosis was achieved in 99 out of 100 cases across various organs, demonstrating high efficacy in obtaining tissue samples.

The procedure had a low complication rate, with only 8 minor complications and 3 major complications reported, indicating that this image-guided biopsy technique is safe for use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a single needle type for all image-guided biopsies: results of 100 consecutive core biopsies in various organs using a novel tri-axial, end-cut needle. Diederich, S., Padge, B., Vossas, U., et al.[2019]

Transjugular liver biopsy using a semi-automatic Tru-cut system was successful in 94% of the 85 patients studied, providing good quality tissue samples for diagnosis in 89% of cases, making it a reliable method for evaluating liver disorders, especially in patients with coagulopathies.

While the procedure is generally safe, there were some complications, including a 1% rate of procedure-related mortality and 8 total complications, indicating that while effective, careful consideration of risks is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transjugular liver core biopsy: indications, results, and complications]. Dinkel, HP., Wittchen, K., Hoppe, H., et al.[2019]

The new biopsy needle device demonstrated a 100% success rate in obtaining diagnostic liver biopsy specimens with fewer needle passes (1.1 passes per patient) compared to the Quick-Core biopsy needle (1.8 passes per patient), indicating greater efficiency.

Specimens obtained with the new device were longer and showed no tissue fragmentation, while 25% of specimens from the Quick-Core needle were fragmented, highlighting the new device's superior sample adequacy and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a new aspiration needle device and the Quick-Core biopsy needle for transjugular liver biopsy. Ishikawa, T., Kamimura, H., Tsuchiya, A., et al.[2019]

A new stereotactic device for PET image-guided biopsies was developed and tested, showing a mean procedure time of less than 20 minutes, which is faster than traditional CT-guided biopsies.

The device demonstrated an accuracy of 5.0±1.3mm in targeting tumors, surpassing the standard accuracy criteria for biopsies of tumors with a diameter of 10mm, indicating its potential effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel stereotactic frame for real PET-guided biopsies: A preclinical proof-of-concept. Cortes-Rodicio, J., Sanchez-Merino, G., Garcia-Fidalgo, MA., et al.[2018]

In a study involving 29 patients with liver dysfunction, an automated device for transjugular liver biopsy successfully obtained adequate tissue samples in all cases, with an average length of 12.0 mm, allowing for confident histopathologic diagnoses.

The procedure was performed without any complications, highlighting the safety and efficacy of using an automated device for liver biopsies in patients where traditional methods were contraindicated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transjugular liver biopsy with an automated device. Kardache, M., Soyer, P., Boudiaf, M., et al.[2004]

In a study involving 503 thyroid nodules, the semi-automated core needle biopsy showed a significantly lower inconclusive rate (11.9%) compared to the automated needle (20.9%), indicating it may provide clearer diagnostic results.

Both biopsy methods were found to be safe, with low complication rates; however, the semi-automated needle demonstrated slightly better diagnostic performance with comparable sensitivity and specificity for detecting malignancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic efficacy, performance and safety of side-cut core needle biopsy for thyroid nodules: comparison of automated and semi-automated biopsy needles. Park, JY., Yi, SY., Baek, SH., et al.[2022]

In a study of 6613 image-guided liver biopsies performed over 12 years, the overall incidence of major adverse events was low at 0.7%, with the most common being hematoma requiring intervention (0.5%).

Significant risk factors for post-biopsy bleeding included having more than 2 biopsy passes, a platelet count of 50,000/μL or less, and being female, indicating that careful patient selection can enhance the safety of this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Adverse Events Related to Image-Guided Liver Biopsy. Boyum, JH., Atwell, TD., Schmit, GD., et al.[2022]

A study of 811 patients undergoing 824 image-guided thoracic biopsies found that the procedure is safe, with only 4.8% experiencing major complications and 20.8% minor complications, particularly favoring ultrasound guidance and certain lesion characteristics.

The diagnostic accuracy of the biopsies was very high, with a sensitivity of 96.5% and specificity of 100%, indicating that image-guided lung biopsies are effective for diagnosing pulmonary lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and diagnostic performance of image-guided lung biopsy in the targeted therapy era. Busso, M., Sardo, D., Garetto, I., et al.[2022]

EUS-TV-FNA, a technique for obtaining tissue samples from thoracic and abdominal lesions, demonstrated a high diagnostic yield of 86% and significant clinical impact in 88% of cases, based on a retrospective study of 49 patients.

The procedure was found to be safe, with only three incidents reported, including two minor hematomas and one self-limited bleeding, suggesting that EUS-TV-FNA can be a viable option when traditional methods are not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience. Garcia-Sumalla, A., Subtil, JC., de la Serna, C., et al.[2020]

The novel biopsy needle detection technique significantly enhances needle visibility by effectively reducing background tissue artifacts, making it easier to locate the needle even in low-contrast situations.

This method improves the accuracy of estimating the needle's trajectory angle and tip position, allowing for reliable detection without external devices, which could enhance the safety and efficacy of biopsy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-Based Needle Identification Using Image Analysis and Needle Library Matching for Ultrasound-Guided Kidney Biopsy: A Feasibility Study. Park, S., Beom, DG., Bae, EH., et al.[2023]

A new device was developed to improve the accuracy of biopsy needle placement using computed tomography, showing promising results in both phantom studies and real patient applications.

In a phantom study, 85% of needle placements were within +/- 3 degrees of the target angle, and in actual patient use, the device maintained this accuracy, demonstrating its potential effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guidance device for CT-guided procedures. Reyes, GD.[2004]

Citations

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Real-time three-dimensional optical coherence tomography ... We have developed and demonstrate an integrated core-needle biopsy system that utilizes catheter-based 3-D OCT for real-time image-guidance for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1531864/

Optical Coherence Tomography: An Emerging Technology for ... OCT can provide cross-sectional images of tissue structure on the micron scale in situ and in real time. Using OCT in combination with catheters and endoscopes ...

3. opg.optica.org opg.optica.org/abstract.cfm?uri=ol-25-20-1520

Imaging needle for optical coherence tomography The OCT imaging needle is inserted directly into soft solid tissues or organs to deliver, scan, and collect a single-mode optical beam.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1931524425000362

Optical coherence tomography for the qualitative analysis ... This study aimed to explore the use of OCT for imaging the thyroid tissue by verifying its clinical feasibility and qualitatively analyzing the OCT imaging ...

5. ajronline.org ajronline.org/doi/10.2214/AJR.11.7284

Ultrasound-Guided Optical Coherence Tomography Needle ... We propose a technique whereby an OCT needle probe is inserted under ultrasound guidance for in situ assessment of the tumor margin.

6. hologic.com hologic.com/hologic-products/breast-health-solutions/sertera-spring-loaded-core-breast-biopsy-device

Sertera® Spring-loaded Core Breast Biopsy Device Hologic's Sertera spring-loaded core breast biopsy device is designed for ultrasound-guided breast tissue sampling procedures ... Safety Data · Package Inserts ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3638027/

Image-Directed Fine Needle Aspiration Biopsy of the ... Safety devices included 1) a patient safety technology - the mechanical aspirating syringe (reciprocating procedure device), and 2) a healthcare worker safety ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K160316.pdf

K160316.pdf - accessdata.fda.gov EasyCut Semi-Automatic Biopsy Needle is intended for soft tissue biopsy or aspiration. The device is not intended for use in bone. • MDL Biopsy ...

9. ascopubs.org ascopubs.org/doi/10.1200/JGO.18.10550

Reusable Core Needle Biopsy Device for Low-Resource ... The device must prevent internal driver contamination and match the standard tissue sample size. We report the design and development of a ...

10. ajronline.org ajronline.org/doi/10.2214/ajr.182.4.1821075?doi=10.2214/ajr.182.4.1821075

MRI-Guided Breast Biopsy: Clinical Experience with 14 ... The stainless steel biopsy needle is MRI-safe and allows more reliable, more efficient, and less expensive sampling. The 1.5-T closed MRI scanner provides high ...