Renal Cell Carcinoma
Conditions
Keywords
Fluorescence, Imaging, Partial nephrectomy, Radical nephrectomy
Brief 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.
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.
Interventions
DRUGOTL38
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.
DEVICEIntraoperative fluorescence imaging system
Sponsors
Chandru Sundaram
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for localized RCC treated with partial nephrectomy To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * Have primary or suspected diagnosis of RCC, with presence of cT1-2 renal mass by diagnostic CT assessment. * Scheduled for partial nephrectomy of renal mass. * Expected survival of at least 3 months. * Written informed consent available. * ECOG ≤ 1 (Appendix G). * Negative serum or urine pregnancy test within 24 hours for females of child bearing age * Recovered from toxicity of any prior therapy to ≥ grade 1. Inclusion criteria for advanced RCC treated with radical nephrectomy To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: * ≥ 18 years of age. * Have pathologic or suspected diagnosis of RCC with presence of cT1-4 renal mass and evidence of nodal or metastatic involvement by diagnostic CT assessment * Scheduled for radical nephrectomy and lymph node dissection. * Expected survival of at least 3 months. * ECOG ≤ 2. * Negative serum or urine pregnancy test within 24 hours for females of child bearing age. * Recovered from toxicity of any prior therapy to ≥ grade 1 * Written informed consent available.
Exclusion criteria
for both localized and advanced RCC * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Partial Nephrectomy 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.
OTL38: 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 system | 10 |
| Radical Nephrectomy 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.
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. | 0 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Partial Nephrectomy |
|---|---|---|
| Age, Customized 50-70 | 10 Participants | 10 Participants |
| BMI | 29.4 kg/m^2 | 29.4 kg/m^2 |
| Negative Post-Surgical Margins | 10 Participants | 10 Participants |
| Pathologic Tumor Stage Benign | 1 Participants | 1 Participants |
| Pathologic Tumor Stage pT1a | 8 Participants | 8 Participants |
| Pathologic Tumor Stage pT3a | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants |
| Region of Enrollment United States | 10 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 0 |
| other Total, other adverse events | 1 / 10 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 0 |
Outcome results
Primary
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.
Time frame: During procedure, an average of 2 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Partial Nephrectomy | Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens | 10 Participants |