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NCT02907073 · ADVERSE EVENTS

Adverse events

Positron Emission Tomography (PET) Imaging Studies With NIS Reporter · Source last updated 2019-05-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse event data collection was defined as 24 hours following last administration of study treatment.
Other-event reporting threshold
0%

The study in eight healthy volunteers was completed. The study arms in myeloma and endometrial cancer were terminated due to pursuing IND.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Healthy Volunteers

At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion \[18F\]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F

0 / 80 / 80 / 8
Myeloma Patients

For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three myeloma patients when the site is accessible for biopsy. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F

0 / 00 / 00 / 0
Endometrial Cancer Patients

For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F

0 / 00 / 00 / 0

Group identifiers: EG000: Healthy Volunteers · EG001: Myeloma Patients · EG002: Endometrial Cancer Patients

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      The study in eight healthy volunteers was completed. The study arms in myeloma and endometrial cancer were terminated due to pursuing IND.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        8
        description
        At the study visit, healthy subjects will have an initial physical exam, urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration and blood sampling. Vital signs, and blood samples will be obtained. Subjects will receive an infusion \[18F\]BF4 over 1 minute and PET imaging will begin. Three (3) PET/CT scanning procedures will be performed over a period of approximately 4 hours with two rest breaks in between. Venous blood samples for clinical laboratory tests will be taken before radiotracer administration and at 1.5 hours post-administration of radiotracer. In addition, venous blood samples will be taken during the PET/CT scans to determine blood pharmacokinetics and metabolite evaluation. Physical exam will be repeated at the end of the study. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        8
        serious Num Affected
        0
        serious Num At Risk
        8
        title
        Healthy Volunteers
      2. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three myeloma patients when the site is accessible for biopsy. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Myeloma Patients
      3. deaths Num Affected
        0
        deaths Num At Risk
        0
        description
        For cancer patients undergoing virus treatments, subjects will undergo \[18F\]BF4-PET/CT imaging at baseline before virus administration and at day 9 following virus treatment. Subjects will be screened by physician specialists within their clinics. Subjects who qualify for the study will return to the clinic within 30 days of screening, have a urine pregnancy test (if applicable) and will have catheters placed for i.v. drug administration. Vital signs will be obtained. All subjects will then receive a single i.v. bolus of \[18F\]BF4 for injection and PET/CT imaging will begin. Biopsies will be performed to confirm NIS expression in tissue of tumor regions showing uptake of \[18F\]BF4 in up to three endometrial cancer patients when the site is accessible for biopsy. BF4: Single IV dose of 9-11 mCi sodium \[Fluorine-18\] radiolabeled B4\^F
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        0
        title
        Endometrial Cancer Patients
      frequency Threshold
      0
      time Frame
      Adverse event data collection was defined as 24 hours following last administration of study treatment.

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      Preserved source evidence · Not medical advice