Renal Cell CarcinomaNCT02645409
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
A study testing OTL38 and Intraoperative fluorescence imaging system in people with Renal Cell Carcinoma, run by Chandru Sundaram at 2 sites in United States.
Trial summary
Primary To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- OTL38 and Intraoperative fluorescence imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Dec 2015to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
None listed.
Who cannot join
- History of any anaphylactic reaction, any severe allergy, or any allergy to folate.
- Brain metastases
- Baseline GFR < 50 mL/min/1.73m2)
- Hepatic toxicity ≥ Grade 2 (using CTCAE version 4 standard definitions).
- Participation in another investigational drug trial either concurrently or 30 days prior to surgery
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
- Known sensitivity to fluorescent light
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Hospital
Indianapolis, Indiana, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Primary
- To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.
Read the detailed description
Administration of the study drug, OTL38, will begin prior to skin incision in the preoperative area where safety monitoring will occur. The tumor resection occurs approximately 2 hours after being brought back to the operating room and so there is no wait time between infusion and being taken back to operating room. Intraoperative fluorescent imaging will be utilized in parallel with the standard operating procedure to capture images during surgery. Images also will be taken of the excised specimen on the back table. The excised specimen will be sent to the pathology department for fluorescent imaging and immunohistochemistry for FR. Subjects will have a 2-5 day hospital stay (normal nephrectomy recovery period) where safety measurements will be taken. Final safety measurements will be taken at the 10-day and 1-month follow-up visits.
- Conditions
- Renal Cell Carcinoma
- Being tested
- OTL38, Intraoperative fluorescence imaging system
- Keywords
- Fluorescence, Imaging, Partial nephrectomy, Radical nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTL38Drug
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Intraoperative fluorescence imaging systemDevice
| Study group | Role | What they receive |
|---|---|---|
| Partial nephrectomy | Experimental | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. Receives: Drug: OTL38; Device: Intraoperative fluorescence imaging system |
| Radical nephrectomy | Experimental | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. Receives: Drug: OTL38; Device: Intraoperative fluorescence imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens
Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.
Measured: During procedure, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start29 Dec 2015
- Primary completion20 Mar 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandru Sundaram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chandru Sundaram, Indiana University
- Investigators
- Chandru P. Sundaram, MD, Principal investigator, Indiana University School of Medicine, Indiana University Simon Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645409
- Sponsor's protocol ID
- IUSCC-0546
- Status last verified
- Feb 2020
- First submitted
- 8 Dec 2015
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02645409
- Acronym / sponsor ID
- IUSCC-0546
- Conditions
- Renal Cell Carcinoma
- Keywords
- Fluorescence, Imaging, Partial nephrectomy, Radical nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chandru SundaramUniversity, hospital or other
- Study start
- 29 Dec 2015 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary
- To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.
Detailed description
Administration of the study drug, OTL38, will begin prior to skin incision in the preoperative area where safety monitoring will occur. The tumor resection occurs approximately 2 hours after being brought back to the operating room and so there is no wait time between infusion and being taken back to operating room. Intraoperative fluorescent imaging will be utilized in parallel with the standard operating procedure to capture images during surgery. Images also will be taken of the excised specimen on the back table. The excised specimen will be sent to the pathology department for fluorescent imaging and immunohistochemistry for FR. Subjects will have a 2-5 day hospital stay (normal nephrectomy recovery period) where safety measurements will be taken. Final safety measurements will be taken at the 10-day and 1-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial nephrectomy | Experimental | Drug: OTL38, Device: Intraoperative fluorescence imaging systemOTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. |
| Radical nephrectomy | Experimental | Drug: OTL38, Device: Intraoperative fluorescence imaging systemOTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- History of any anaphylactic reaction, any severe allergy, or any allergy to folate.
- Brain metastases
- Baseline GFR < 50 mL/min/1.73m2)
- Hepatic toxicity ≥ Grade 2 (using CTCAE version 4 standard definitions).
- Participation in another investigational drug trial either concurrently or 30 days prior to surgery
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 |
|---|---|---|
| OTL38OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. | Drug | Partial nephrectomy, Radical nephrectomy |
| Intraoperative fluorescence imaging system | Device | Partial nephrectomy, Radical nephrectomy |
Primary outcome
Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens
Time frame: During procedure, an average of 2 hours
Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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RecruitingPhase 2/3
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Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Chandru P. Sundaram, MD principal investigator
Indiana University School of Medicine, Indiana University Simon Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTL38 and Intraoperative fluorescence imaging system in people with Renal Cell Carcinoma, run by Chandru Sundaram at 2 sites in United States.
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 0 inclusion and 7 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 25 Feb 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens (time frame: During procedure, an average of 2 hours). 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 25 Feb 2020.