Trial Outcomes & Findings for Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses. (NCT NCT00199888)
NCT ID: NCT00199888
Last Updated: 2022-10-10
Results Overview
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
COMPLETED
PHASE1
26 participants
8 days
2022-10-10
Participant Flow
Participant milestones
| Measure |
124-Iodine-cG250 (124I-cG250)
Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi)/10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
124-Iodine-cG250 (124I-cG250)
Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi)/10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Baseline characteristics by cohort
| Measure |
124-Iodine-cG250 (124I-cG250)
n=26 Participants
Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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19 Participants
n=5 Participants
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Age, Categorical
>=65 years
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7 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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17 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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26 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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24 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
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Region of Enrollment
United States
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26 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 8 daysPopulation: All patients who enrolled in the study, received 124I-cG250, had evaluable PET scans, had tissue samples analyzed and were PET-positive. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Fifteen patients were PET-positive.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Outcome measures
| Measure |
124-Iodine-cG250 (124I-cG250)
n=15 Participants
Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.
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|---|---|
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Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
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100 percent of PET-positive patients
Interval 78.0 to 100.0
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SECONDARY outcome
Timeframe: 8 daysPopulation: All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and were PET-negative. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Ten patients were PET-negative.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. NPV is the ratio of participants who do not have clear cell RCC to all those who had negative PET scans. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Outcome measures
| Measure |
124-Iodine-cG250 (124I-cG250)
n=10 Participants
Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.
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|---|---|
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Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
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90 percent of PET-negative patients
Interval 55.0 to 100.0
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SECONDARY outcome
Timeframe: 8 daysPopulation: All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and had a pathological diagnosis of clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Sixteen patients had clear cell renal cell carcinoma.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. Sensitivity is defined as the ratio of the proportion of the patients who have clear cell RCC based on pathology and whose PET scans are positive over the number of patients with clear cell RCC. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Outcome measures
| Measure |
124-Iodine-cG250 (124I-cG250)
n=16 Participants
Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.
|
|---|---|
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Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
|
94 percent of clear cell RCC patients
Interval 70.0 to 100.0
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SECONDARY outcome
Timeframe: 8 daysPopulation: All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and did not have clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Nine patients did not have clear cell RCC.
Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3. The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made. Specificity is defined as the number of patients with non-clear cell RCC correctly classified divided by all non-clear cell RCC patients. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered a true-positive. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.
Outcome measures
| Measure |
124-Iodine-cG250 (124I-cG250)
n=9 Participants
Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.
|
|---|---|
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Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.
|
100 percent of non clear cell RCC patients
Interval 66.0 to 100.0
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Adverse Events
124-Iodine-cG250 (124I-cG250)
Serious adverse events
| Measure |
124-Iodine-cG250 (124I-cG250)
n=26 participants at risk
Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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3.8%
1/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Other adverse events
| Measure |
124-Iodine-cG250 (124I-cG250)
n=26 participants at risk
Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.
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|---|---|
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Blood and lymphatic system disorders
Lymphopenia
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23.1%
6/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Hepatobiliary disorders
Hyperbilirubinemia
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34.6%
9/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Investigations
Haemoglobin decreased
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100.0%
26/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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|
Investigations
Aspartate aminotransferase increased
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57.7%
15/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
|
|
Investigations
Blood creatinine increased
|
53.8%
14/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Investigations
Alanine aminotransferase increased
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42.3%
11/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Investigations
Platelet count decreased
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34.6%
9/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Investigations
International normalised ratio increased
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19.2%
5/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Investigations
Activated partial thromboplastin time prolonged
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7.7%
2/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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|
Investigations
Blood alkaline phosphatase increased
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7.7%
2/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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|
Investigations
Blood bicarbonate decreased
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7.7%
2/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Metabolism and nutrition disorders
Hypoalbuminaemia
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96.2%
25/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Metabolism and nutrition disorders
Hyperglycaemia
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92.3%
24/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Metabolism and nutrition disorders
Hypokalaemia
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19.2%
5/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Metabolism and nutrition disorders
Hyponatraemia
|
19.2%
5/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
|
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Metabolism and nutrition disorders
Hypernatraemia
|
19.2%
5/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Metabolism and nutrition disorders
Hyperkalaemia
|
11.5%
3/26 • 35 days
Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.
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Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place