Malignant Lymphoma of Lymph Nodes of Inguinal RegionNerveSpectNCT01731379
Optical Detection of Peripheral Nerve Bundles During Surgery
An observational study of Malignant Lymphoma of Lymph Nodes of Inguinal Region and Malignant Lymphoma of Lymph Nodes of Axillary, run by Philips Healthcare at 1 site in Netherlands.
Trial summary
Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Lymphoma of Lymph Nodes of Inguinal Region, Malignant Lymphoma of Lymph Nodes of Axillary, Malignant Lymphoma of Lymph Nodes of the Cervix
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2012to Oct 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 patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
Who may be able to join
- Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
- Patients that have provided a signed informed consent
- Patients ≥ 18 years old
Who cannot join
- Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
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: In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study
Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. 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. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.
Read the detailed description
The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.
Primary Objective:
The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.
- Conditions
- Malignant Lymphoma of Lymph Nodes of Inguinal Region, Malignant Lymphoma of Lymph Nodes of Axillary, Malignant Lymphoma of Lymph Nodes of the Cervix, Carcinoma of Parotid Gland, Colon Rectal Cancer Tubulovillous Adenocarcinoma, Tumor of Soft Tissue of Head, Face and Neck
- Being tested
- Surgical resection
- Keywords
- spectroscopy, nerve, muscle, fat
- Medical subject headings
- Parotid Neoplasms, Facies, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Also called lymph node dissection, resection of parotid gland, rectal surgery, soft tumor resection
Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
| Study group | Role | What they receive |
|---|---|---|
| Surgical resections | Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation between nerve tissue and its surrounding tissue
Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue 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 startDec 2012
- Primary completionJan 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Lymphoma of Lymph Nodes of Inguinal RegionStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global
- Responsible party
- Sponsor
- Investigators
- Theo Ruers, MD, Principal investigator, Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731379
- Sponsor's protocol ID
- NL 40893.031.12
- Acronym
- NerveSpect
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2012
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Identification of Peripheral Nerve Bundles During Surgery Using Optical Spectroscopy Techniques - a Pilot Study
- ClinicalTrials.gov ID
- NCT01731379
- Acronym / sponsor ID
- NerveSpect / NL 40893.031.12
- Conditions
- Malignant Lymphoma of Lymph Nodes of Inguinal Region, Malignant Lymphoma of Lymph Nodes of Axillary, Malignant Lymphoma of Lymph Nodes of the Cervix, Carcinoma of Parotid Gland, Colon Rectal Cancer Tubulovillous Adenocarcinoma, Tumor of Soft Tissue of Head, Face and Neck
- Keywords
- spectroscopy, nerve, muscle, fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Philips Clinical & Medical Affairs Global
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Oct 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 surgical resection procedures to spare nerve tissue. 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. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.
Detailed description
The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.
Primary Objective:
The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.
Secondary Objective:
During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical resections | – | Procedure: Surgical resectionPatients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
Key inclusion criteria (3 listed)
- Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
- Patients that have provided a signed informed consent
- Patients ≥ 18 years old
Key exclusion criteria (1 listed)
- Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
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 |
|---|---|---|
| Surgical resectionAlso: lymph node dissection, resection of parotid gland, rectal surgery, soft tumor resectionPatients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. | Procedure or surgery | Surgical resections |
Primary outcome
Differentiation between nerve tissue and its surrounding tissue
Time frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue 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 3 Nov 2015.
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 Malignant Lymphoma of Lymph Nodes of Inguinal Region and Malignant Lymphoma of Lymph Nodes of Axillary, 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 3 inclusion and 1 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 3 Nov 2015. 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 nerve tissue and its surrounding 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?
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 3 Nov 2015.