Pulmonary Coin LesionNCT01730365
Optical Detection of Malignancy During Percutaneous Interventions
An observational study of Pulmonary Coin Lesion and Colon Cancer Liver Metastasis, run by Philips Healthcare at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Coin Lesion, Colon Cancer Liver Metastasis, Breast Cancer
- What is being tested?
- Core biopsy procedure
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients are all patients, who are scheduled for a standard core biopsy of lung, liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the "patient informatie" will be used and the informed consent must be signed prior to the intervention.
Who may be able to join
- 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:
Show all 12Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis
Amsterdam, North Holland, 1066 CX
About this study
Official title: Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
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.
Read the detailed description
Primary Objective:
In this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded. Analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. Special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.
- Being tested
- Core biopsy procedure
- Keywords
- spectroscopy, tumour, biopsy, malignancy
- Medical subject headings
- Solitary Pulmonary Nodule, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core biopsy procedureProcedure or surgery
Also called Histological biopsy procedure, Standard biopsy procedure
Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Histological biopsy procedures | Patients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis Receives: Procedure: Core biopsy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation between normal and malignant tissue
Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Coin LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theo Ruers, MD, Principal investigator, Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730365
- Sponsor's protocol ID
- NL40578.031.12
- Status last verified
- Apr 2016
- First submitted
- 4 Oct 2012
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Boer LL, Bydlon TM, van Duijnhoven F, Vranken Peeters MTFD, Loo CE, Winter-Warnars GAO, Sanders J, Sterenborg HJCM, Hendriks BHW, Ruers TJM. Towards the use of diffuse reflectance spectroscopy for real-time in vivo detection of breast cancer during surgery. J Transl Med. 2018 Dec 19;16(1):367. doi: 10.1186/s12967-018-1747-5.
PubMed 30567584
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discrimination of Benign and Malignant Human Tissue During Percutaneous Interventions Using Optical Spectroscopy Techniques
- ClinicalTrials.gov ID
- NCT01730365
- Acronym / sponsor ID
- NL40578.031.12
- Keywords
- spectroscopy, tumour, biopsy, malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
In this observational study the investigators aim to evaluate whether optical spectroscopy can correctly diagnose malignant tissue in the existing clinical workflow of percutaneous interventions in lung, liver, and breast.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded. Analysis of this documentation will provide information for possible alterations of hardware design for improved clinical applicability in the future. Special attention will be paid to observe how the procedure fits in the standard workflow of the radiologist.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Histological biopsy procedures | – | Procedure: Core biopsy procedurePatients with a suspicious lesion in lung or liver or breast who are planned for a standard core biopsy procedure. And patients planned for percutaneous RFA (Radiofrequency Ablation) of colorectal liver metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are all patients, who are scheduled for a standard core biopsy of lung, liver or breast; or percutaneous RFA of liver in the Netherlands Cancer Institute (NKI-AvL), Amsterdam, The Netherlands. In the enrollment process the "patient informatie" will be used and the informed consent must be signed prior to the intervention.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core biopsy procedureAlso: Histological biopsy procedure, Standard biopsy procedureCore biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis. | Procedure or surgery | Histological biopsy procedures |
Primary outcome
Differentiation between normal and malignant tissue
Time frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at normal and malignant measurement locations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 30567584de Boer LL, Bydlon TM, van Duijnhoven F, Vranken Peeters MTFD, Loo CE, Winter-Warnars GAO, Sanders J, Sterenborg HJCM, Hendriks BHW, Ruers TJM. Towards the use of diffuse reflectance spectroscopy for real-time in vivo detection of breast cancer during surgery. J Transl Med. 2018 Dec 19;16(1):367. doi: 10.1186/s12967-018-1747-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theo Ruers, MD principal investigator
Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Coin Lesion and Colon Cancer Liver Metastasis, run by Philips Healthcare at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation between normal and malignant tissue (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.