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

Trial Summary

What is the purpose of this trial?

To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.

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 data supports the effectiveness of the treatment tVisio-1 in the clinical trial Imaging Device for Needle Biopsy?

The research suggests that using a single needle design for image-guided biopsies in various organs is feasible and effective, which may support the use of tVisio-1 if it involves similar technology. Additionally, studies on automated and semi-automated biopsy devices show promising results in terms of diagnostic efficacy and safety, indicating potential effectiveness for tVisio-1. ^{1 2 3 4 5}

Is the imaging device for needle biopsy generally safe for humans?

The imaging device for needle biopsy, including methods like endoscopic ultrasound-guided biopsy, appears to be generally safe with few incidents reported, such as minor bleeding or hematomas. However, caution is advised for patients with certain conditions like liver cirrhosis or hypervascular tumors, as they may have a higher risk of complications. ^{6 7 8 9 10}

How does the Imaging Device for Needle Biopsy treatment differ from other treatments?

This treatment uses a unique precision placement technique for biopsy needles, allowing for accurate and less traumatic procedures by using servo-controlled micro-pulses to guide the needle. It also includes an anti-seeding system to prevent the spread of tumor cells during the procedure, which is not commonly found in other biopsy methods. ^{3 4 11 12 13}

Research Team

Rahul A Sheth, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England 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. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Transjugular liver core biopsy: indications, results, and complications]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transjugular liver biopsy with an automated device. [2004]

4. England pubmed.ncbi.nlm.nih.gov

Model-Based Needle Identification Using Image Analysis and Needle Library Matching for Ultrasound-Guided Kidney Biopsy: A Feasibility Study. [2023]

5. United States 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. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Safety and diagnostic performance of image-guided lung biopsy in the targeted therapy era. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Adverse Events Related to Image-Guided Liver Biopsy. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided transvascular needle biopsy of thoracic and abdominal lesions: a multicenter experience. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Adverse Events of Different Endoscopic Ultrasound-Guided Tissue Acquisition Methods: A Single-Center Retrospective Analysis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of a new aspiration needle device and the Quick-Core biopsy needle for transjugular liver biopsy. [2019]

11. Italy pubmed.ncbi.nlm.nih.gov

A new method to gently place biopsy needles or treatment electrodes into tissues with high target precision. [2017]

12. Italy pubmed.ncbi.nlm.nih.gov

A novel stereotactic frame for real PET-guided biopsies: A preclinical proof-of-concept. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

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