2706 Participants Needed

Nanomechanical Phenotype Test for Breast Cancer

(ANGEL Trial)

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Overseen ByTobias Appenzeller
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: ARTIDIS AG
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict the type and aggressiveness of breast tumors using a technology called nanomechanical phenotype. The goal is to determine if this method provides information about breast tumors more effectively than traditional techniques. It involves patients requiring a breast biopsy, a standard procedure for examining suspicious breast tissue. Suitable candidates for this trial are those needing a breast biopsy to diagnose a potential breast issue and who can consent to participate. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future breast cancer diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the nanomechanical phenotype test is safe for use in breast biopsy procedures?

Research has shown that the nanomechanical phenotype test, which measures tissue stiffness and firmness, has been used in breast cancer studies. These studies examined hundreds of breast biopsy samples and found that the test can distinguish between healthy tissue, non-cancerous lumps, and cancerous lumps.

This test is safe because it uses tissue already collected during a biopsy, without adding new substances or requiring extra procedures. Since it relies on standard biopsy tissue, it does not increase any risk to the patient.

Overall, evidence suggests that patients tolerate the nanomechanical phenotype test well, with no reported issues from the test itself.12345

Why are researchers excited about this trial?

Researchers are excited about using ARTIDIS nanomechanical measurements for early breast lesions because this technique offers a novel way to assess breast tissue during biopsies. Unlike traditional methods that rely heavily on imaging and histopathology, ARTIDIS measures the mechanical properties of tissue at a nanoscale level, potentially providing more precise and immediate insights into whether a lesion is benign or malignant. This could lead to faster, more accurate diagnoses and a more personalized treatment pathway for patients, reducing the waiting time and anxiety associated with current diagnostic methods.

What evidence suggests that the nanomechanical phenotype test is effective for predicting tumor type and aggressiveness?

Research has shown that a new test, the nanomechanical phenotype test, can help predict the type and severity of breast tumors. In this trial, all patients referred for a core needle or vacuum-assisted breast biopsy will have their diagnostic biopsy measured using this test before returning to the standard care pathway. Studies suggest it might be useful in understanding how tumors respond to treatments given before surgery. This test examines tiny changes in the tissue, providing important information about the cancer. Early findings indicate that this method could help doctors better diagnose and plan treatment for breast cancer. Researchers are exploring whether this approach offers more precise insights than traditional methods.678910

Who Is on the Research Team?

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Alastair Thompson, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

You are capable of understanding and consent to sign a legally-binding document.
You are being recommended for a breast biopsy to diagnose a condition.
You have a performance status ranging from 0 to 3 on the Eastern Cooperative Oncology Group scale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Biopsy and Initial Assessment

Participants undergo a breast biopsy procedure and nanomechanical phenotype measurement

1 day
1 visit (in-person)

Follow-up

Participants with benign lesions are followed for 30 days, while those with cancer are followed up to 10 years

10 years
Twice yearly for the first 2 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

  • Nanomechanical Phenotype Test

How Is the Trial Designed?

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Treatment groups

Experimental Treatment

Group I: Human subjects requiring breast biopsyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ARTIDIS AG

Lead Sponsor

Trials
1
Recruited
2,700+

Citations

Study Details | NCT06085833 | ARTIDIS Nanomechanical ...

This study aims to determine the effectiveness of the nanomechanical phenotype test in predicting tumor type, tumor aggressiveness, and neoadjuvant treatment ...

The Nanomechanical Phenotype of Lobular Breast Cancer

This study presents the first integrated characterization of the nanomechanical phenotype of ILC, which will be further validated in the ongoing ...

ARTIDIS Nanomechanical Generated Measurements for ...

This study aims to determine the effectiveness of the nanomechanical phenotype test in predicting tumor type, tumor aggressiveness, and ...

Nano-mechanical Phenotype as a Promising Biomarker to ...

These nano-mechanical insights will advance our understanding of cancer progression and provide a tool in diagnosing cancer and screening an ...

Abstract PO5-19-12: Innovative Trial Design: ARTIDIS ...

This study harnesses the novel concept of evaluating diagnostic cores for nanomechanical features at the time of core biopsy.

Study Details | NCT06085833 | ARTIDIS Nanomechanical ...

This is a multi-center, blinded, single-arm study designed to collect nanomechanical signature measurement data of biopsy material taken for clinical diagnostic ...

The Revolution in Breast Cancer Diagnostics - PubMed Central

The obtained nanomechanical signature is different for healthy tissue, benign lesions, and malignant lesions and provides an in-depth view of cancer at the ...

The Nanomechanical Phenotype of Lobular Breast Cancer

Conducted between 2016 and 2019, the clinical study included 588 fresh breast biopsy samples from 545 suspected breast cancer patients. Samples ...

Nanomechanical characterization of soft nanomaterial ...

AFM data revealed that triptorelin-MNPs have a 14-fold higher affinity for breast cancer cells than for normal breast cells. Moreover, the adhesive strength ...

The Nanomechanical Phenotype of Lobular Breast Cancer

Fresh clinical biopsy samples, either core needle or vacuum-assisted, were measured using the ... High risk. 5. 4.5%. Intermedian risk. 5. 4.5%. Low risk. 11. 9.8 ...