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NCT02907073 · OUTCOME

Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients

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.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Baseline, Day 9

What was measured

Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.

Analysis population: Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.

Groups in this outcome

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

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

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Healthy Volunteers0
Myeloma Patients0
Endometrial Cancer Patients0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.
groups
  1. 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
    OG000
    title
    Healthy Volunteers
  2. 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
    OG001
    title
    Myeloma Patients
  3. 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
    OG002
    title
    Endometrial Cancer Patients
population Description
Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.
reporting Status
POSTED
time Frame
Baseline, Day 9
title
Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients
type
SECONDARY

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Preserved source evidence · Not medical advice