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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00237314 | Other Identifier | Johns Hopkins University IRB |
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This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (111In-XYIMSR-01) | Experimental | Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 111In-XYIMSR-01 | Drug | Unite Dose: 10.5±1 mCi of 111In-XYIMSR-01 Route of administration: Intravenous catheter placed in an antecubital vein or an equivalent venous access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5. | From enrollment to the end of treatment at 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution assessed by SPECT/CT images | To determine the biodistribution and radiation dosimetry of 111In-XYIMSR-01 | From enrollment to the end of treatment at 1 week |
| Radiation Dosimetry assessed by SPECT/CT images |
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Inclusion Criteria:
Males or female sex
≥18 years of age
Willingness to provide signed informed consent and comply with all protocol requirements
Histological confirmation of RCC with a clear cell component
2-10 sites of disease measuring ≥1.5 cm on contrast-enhanced CT and/or MRI imaging of the chest, abdomen and pelvis performed ≤60 days prior to the date of study enrollment
Screening clinical laboratory values as specified below:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasser Ged, MBBS | Contact | 410-955-8893 | yged1@jhmi.edu | |
| Jasmine Brooks | Contact | jbrook54@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yasser Ged, MBBS | Johns Hopkins University SKCCC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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To determine radiation dosimetry of 111In-XYIMSR-01
| From enrollment to the end of treatment at 1 week |
| Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time | To quantify the total radioactivity (expressed in counts per minute [CPM]) in plasma samples at specified time points following injection of 111In-XYIMSR-01 | From enrollment to the end of treatment at 1 week |
| Number of lesions detected | Investigating the role of 111In-XYIMSR-01 SPECT/CT as a diagnostic assessment tool in comparison to conventional imaging. To compare the number of lesions detected with 111In-XYIMSR-01 SPECT/CT in comparison to conventional imaging all imaging modalities | From enrollment to the end of treatment at 1 week |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |