CompletedNot Applicable

Optical Detection of Malignancy During Percutaneous Interventions

Netherlands104 participantsStarted 2012-10

Plain-language summary

Investigation of application possibilities of optical spectroscopy within the field of oncology. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. biopsy needle) would enlarge the accuracy and reliability of these devices. The purpose is to improve and speed up the diagnostics and therapy of the malignancies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with a suspicious lesion in lung or liver who are scheduled for a standard core biopsy procedure * Patient planned for percutaneous RFA of colorectal liver metastasis * Written informed consent * Patients ≥ 18 years old * Breast patients with a BIRADS score 4 or 5 General Exclusion criteria: * Patients who have higher risk of bleeding * Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy Breast Specific Exclusion criteria: * Patients who have a history of breast cancer and/or who have received prior chemotherapy, endocrine therapy, or radiation therapy * Patients who have breast implants * Patients needing a stereotactic breast biopsy (i.e. non palpable-, ultrasound opaque lesions)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differentiation between normal and malignant tissue

Timeframe: Day 0

Trial details

NCT IDNCT01730365

SponsorPhilips Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

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