Kidney CancerNCT02073110
Optical Biopsy to Improve the Diagnosis of Kidney Cancer
An observational study of Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM) that are incidentally discovered by abdominal radiological imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Percutaneous Optical Biopsy (OCT and DRS)
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2013to Dec 2016
- 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: Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Who may be able to join
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging suspect for RCC
- Scheduled for total or partial nephrectomy or for laparoscopic cryoablation.
- Signed informed consent
Who cannot join
- Patients with a renal mass that are not candidates for active treatment will be excluded from the study
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Free University Medical Center
Amsterdam, 1081 HV
RJA van Moorselaar, MD. PhD., +31204440272, Rja.vanmoorselaar@vumc.nl
- Recruiting
Academic Medical Center
Amsterdam, 1105 AZ
MP Laguna Pes, MD. PhD., +31205666928, m.p.lagunapes@amc.uva.nl
Peter Wagstaff, MD., +31205666493, p.g.wagstaff@amc.uva.nl
About this study
Official title: Optical Biopsy to Improve the Diagnosis of Kidney Cancer: a Prospective, Observational, Multicentre, In-vivo Study
Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM) that are incidentally discovered by abdominal radiological imaging. However, 30% of resected SRMs appear benign on histological examination. Conventional biopsy is currently used to provide pathological information prior to resection. However, its non-diagnostic value is high, up to 33% in SRMs, showing the need for diagnostic improvement.
The investigators have shown that optical biopsy (OB) can differentiate malignant from benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical study. The investigators will use an OB probe that can be combined with a needle puncture during classical biopsy procedures, additionally providing real time micro-scale images containing quantitative information about tissue properties. The investigators are convinced that OB will greatly improve the diagnosis of renal tumor pathology.
Read the detailed description
Rationale:
Renal biopsies can be used in patients with renal mass lesions to diagnose whether it concerns a malignant or benign mass. In case of malignancy, surgery will be the following step. However, 7 to 33% of biopsies are non-diagnostic, what can result in unnecessary surgery (even up to 30% in small renal masses). The investigators think that optical biopsy (OB), a new diagnostic tool based on the absorption en reflection of light in tissues, reduces the non-diagnostic biopsy rate. This could have a direct impact on the quality of life of the patients that are therefore scheduled for an unnecessary surgical procedure. Also, concerns about overtreatment have led to the concept of focal therapy, a selective patient tailored nephron sparing surgical or ablation technique of a lesion, reducing lifetime morbidity and side effects without compromising life expectancy. For this novel form of treatment, accurate identification, grading and demarcation of a lesion is crucial and OB is the ideal platform to provide this approach to an improved cure.
Objectives:
Primary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy
Secondary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy and in distinguishing among the 3 main RCC subtypes
- The accuracy of the combination of the DRS and OCT
Study design:
This is a prospective, observational, multi-centre in-vivo study.
Study population:
Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Intervention:
Patients will receive an ultrasound guided percutaneous OB followed by a Core biopsy (CB) during the same procedure. The planned institutional surgical protocol will be followed irrespective of the results of OB and CB. During surgery (radical/partial, open/laparoscopic, percutaneous ablation) a new set of DRS and OCT measurements of the tumor and normal tissue will be performed.
Main study parameters/endpoints:
- To determine the accuracy of OB to differentiate renal tumor pathology from benign tissue by means of minimal invasive quantitative DRS and OCT.
- To determine the differentiation capability of OCT this combined technique to distinguish between the three most common RCC sub-types.
- To determine whether OB is a good alternative to the percutaneous biopsy for diagnosing renal cancer.
- Conditions
- Kidney Cancer
- Being tested
- Percutaneous Optical Biopsy (OCT and DRS)
- Keywords
- Kidney cancer, Renal mass, Small renal mass, Optical Coherence Tomography, OCT, Diffuse Reflectance Spectroscopy, DRS, Optical Biopsy, OB
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Optical Biopsy (OCT and DRS)Device
| Study group | Role | What they receive |
|---|---|---|
| ≥ 18 years, solid enhancing renal mass suspected for RCC | Not described Receives: Device: Percutaneous Optical Biopsy (OCT and DRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of DRS and OCT in the detection of renal malignancy
By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.
Measured: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
Secondary outcomes (1)
The sensitivity and specificity of DRS and OCT in differentiating between the three main RCC subtypes
By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.
Measured: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
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 Kidney CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- MP Laguna Pes, MD. PhD., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)JJMCH de la Rosette, MD. PhD., Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073110
- Sponsor's protocol ID
- NL41985.018.12
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buijs M, Wagstaff PGK, de Bruin DM, Zondervan PJ, Savci-Heijink CD, van Delden OM, van Leeuwen TG, van Moorselaar RJA, de la Rosette JJMCH, Laguna Pes MP. An In-vivo Prospective Study of the Diagnostic Yield and Accuracy of Optical Biopsy Compared with Conventional Renal Mass Biopsy for the Diagnosis of Renal Cell Carcinoma: The Interim Analysis. Eur Urol Focus. 2018 Dec;4(6):978-985. doi: 10.1016/j.euf.2017.10.002. Epub 2017 Oct 24.
PubMed 29079496
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Biopsy to Improve the Diagnosis of Kidney Cancer: a Prospective, Observational, Multicentre, In-vivo Study
- ClinicalTrials.gov ID
- NCT02073110
- Acronym / sponsor ID
- NL41985.018.12
- Conditions
- Kidney Cancer
- Keywords
- Kidney cancer, Renal mass, Small renal mass, Optical Coherence Tomography, OCT, Diffuse Reflectance Spectroscopy, DRS, Optical Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 27 Feb 2014 (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.
Data from the American Cancer Society shows a 70% increase in incidence of kidney and renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal masses (SRM) that are incidentally discovered by abdominal radiological imaging. However, 30% of resected SRMs appear benign on histological examination. Conventional biopsy is currently used to provide pathological information prior to resection. However, its non-diagnostic value is high, up to 33% in SRMs, showing the need for diagnostic improvement.
The investigators have shown that optical biopsy (OB) can differentiate malignant from benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2 clinical study. The investigators will use an OB probe that can be combined with a needle puncture during classical biopsy procedures, additionally providing real time micro-scale images containing quantitative information about tissue properties. The investigators are convinced that OB will greatly improve the diagnosis of renal tumor pathology.
Detailed description
Rationale:
Renal biopsies can be used in patients with renal mass lesions to diagnose whether it concerns a malignant or benign mass. In case of malignancy, surgery will be the following step. However, 7 to 33% of biopsies are non-diagnostic, what can result in unnecessary surgery (even up to 30% in small renal masses). The investigators think that optical biopsy (OB), a new diagnostic tool based on the absorption en reflection of light in tissues, reduces the non-diagnostic biopsy rate. This could have a direct impact on the quality of life of the patients that are therefore scheduled for an unnecessary surgical procedure. Also, concerns about overtreatment have led to the concept of focal therapy, a selective patient tailored nephron sparing surgical or ablation technique of a lesion, reducing lifetime morbidity and side effects without compromising life expectancy. For this novel form of treatment, accurate identification, grading and demarcation of a lesion is crucial and OB is the ideal platform to provide this approach to an improved cure.
Objectives:
Primary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy
Secondary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy and in distinguishing among the 3 main RCC subtypes
- The accuracy of the combination of the DRS and OCT
Study design:
This is a prospective, observational, multi-centre in-vivo study.
Study population:
Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Intervention:
Patients will receive an ultrasound guided percutaneous OB followed by a Core biopsy (CB) during the same procedure. The planned institutional surgical protocol will be followed irrespective of the results of OB and CB. During surgery (radical/partial, open/laparoscopic, percutaneous ablation) a new set of DRS and OCT measurements of the tumor and normal tissue will be performed.
Main study parameters/endpoints:
- To determine the accuracy of OB to differentiate renal tumor pathology from benign tissue by means of minimal invasive quantitative DRS and OCT.
- To determine the differentiation capability of OCT this combined technique to distinguish between the three most common RCC sub-types.
- To determine whether OB is a good alternative to the percutaneous biopsy for diagnosing renal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ≥ 18 years, solid enhancing renal mass suspected for RCC | – | Device: Percutaneous Optical Biopsy (OCT and DRS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging suspect for RCC
- Scheduled for total or partial nephrectomy or for laparoscopic cryoablation.
- Signed informed consent
Key exclusion criteria (1 listed)
- Patients with a renal mass that are not candidates for active treatment will be excluded from the study
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 |
|---|---|---|
| Percutaneous Optical Biopsy (OCT and DRS) | Device | ≥ 18 years, solid enhancing renal mass suspected for RCC |
Primary outcome
The sensitivity and specificity of DRS and OCT in the detection of renal malignancy
Time frame: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
By measuring the OCT attenuation coefficient (µOCT) and the DRS optical blood absorption (µaHb), and correlating these values to the histopathology results.
1 secondary outcome
The sensitivity and specificity of DRS and OCT in differentiating between the three main RCC subtypes
Time frame: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 29079496Buijs M, Wagstaff PGK, de Bruin DM, Zondervan PJ, Savci-Heijink CD, van Delden OM, van Leeuwen TG, van Moorselaar RJA, de la Rosette JJMCH, Laguna Pes MP. An In-vivo Prospective Study of the Diagnostic Yield and Accuracy of Optical Biopsy Compared with Conventional Renal Mass Biopsy for the Diagnosis of Renal Cell Carcinoma: The Interim Analysis. Eur Urol Focus. 2018 Dec;4(6):978-985. doi: 10.1016/j.euf.2017.10.002. Epub 2017 Oct 24.
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
MP Laguna Pes, MD. PhD. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
JJMCH de la Rosette, MD. PhD. study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MP Laguna Pes, MD. PhD. (+31205666928, m.p.lagunapes@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of DRS and OCT in the detection of renal malignancy (time frame: Participants will undergo OCT/DRS measurements within 2 weeks after inclusion). 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 NCT02073110, 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 27 Feb 2014.