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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA182945 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 89Zr-Trastuzumab Human Dosimetry and Safety |
|
| Cohort 2: Lesion Detection and Safety | Experimental | HER2 Positive Lesion Detection and Safety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-Trastuzumab Human Dosimetry and Safety | Drug | PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. | 30 Days following 89Zr-Trastuzumab Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farrokh Dehdashti, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine @ Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
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Study first enrollment occurred in February 2014 and closed to enrollment 31 December 2017. Subjects were recruited from those patients being seen by medical oncology at Siteman Cancer Center. Planned enrollment was 67 participants with a total of 52 subjects enrolled with evaluable data at the end of the grant period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 89Zr-Trastuzumab Human Dosimetry and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
| FG001 | Cohort 2: Lesion Detection and Safety | HER2 Positive Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 89Zr-Trastuzumab Human Dosimetry and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration | Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. | Posted | Number | participants | 30 Days following 89Zr-Trastuzumab Administration |
|
Subjects were monitored for adverse events for the 30 days following 89Zr-Trastuzumab administration
AE assessment was based on the following: Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related. The event of kidney injury and sepsis noted at 30 day follow up was directly related to SOC therapy and not considered study related AE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 89Zr-Trastuzumab Human Dosimetry and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-neutropenic fever | General disorders | CTCAE (4.0) | Systematic Assessment | One Cohort 1 subject presented with non-neutropenic fever and flu like symptoms 1 day after administration of 89Zr-Trastuzumab and 2 days after receiving standard of care chemotherapy. Subject had similar presentation with prior cycle of SOC therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Farrokh Dehdashti | Washington University School of Medicine in St. Louis | 314-362-1474 | dehdashtif@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 14, 2018 | Oct 21, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| HER2 Positive Lesion Detection and Safety | Drug | Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
|
| BG001 |
| Cohort 2: Lesion Detection and Safety |
HER2 Positive Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort 2: Lesion Detection and Safety | HER2 Positive Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Cohort 2: Lesion Detection and Safety | HER2 Positive Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety: PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety HER2 Positive Lesion Detection and Safety: Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging | 0 | 40 | 0 | 40 | 1 | 40 |
|
| Flu Like Symptoms | General disorders | CTCAE (4.0) | Systematic Assessment | One Cohort 1 subject presented with non-neutropenic fever and flu like symptoms 1 day after administration of 89Zr-Trastuzumab and 2 days after receiving standard of care chemotherapy. Subject had similar presentation with prior cycle of SOC therapy |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Cohort 2 subject presented 26 days post administration of 89Zr-Trastuzumab with sepsis and renal injury |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Cohort 2 subject presented 26 days post administration of 89Zr-Trastuzumab with sepsis and renal injury |
|
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| D017437 |
| Skin and Connective Tissue Diseases |