18F-FSPG PET/CT for Cancer Patients on Therapy

Sponsor
Andrei Iagaru (Other)
Overall Status
Completed
CT.gov ID
NCT02599194
Collaborator
National Cancer Institute (NCI) (NIH)
7
1
1
17.5
0.4

Study Details

Study Description

Brief Summary

The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

Detailed Description

OUTLINE:

Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.

PRIMARY OBJECTIVE:

Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.

SECONDARY OBJECTIVES:
  • Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.

  • Safety and tolerability of 18F-FSPG and 18F-FDG.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Intra-patient comparison of 2 different radiolabelsIntra-patient comparison of 2 different radiolabels
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Actual Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Dec 14, 2016
Actual Study Completion Date :
Dec 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision

Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.

Drug: 18F-FSPG
Administered intravenously (IV)
Other Names:
  • 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid
  • 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate
  • BAY94-9392
  • Drug: 18F-FDG
    Administered intravenously (IV)
    Other Names:
  • [18F]-Fluorodeoxyglucose ([18F]-FDG)
  • Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment [Baseline and up to 2 years]

      Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.

    Secondary Outcome Measures

    1. Number of Treatment-Related Adverse Events [Baseline to up to 2 years]

      Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.

    2. Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs [Baseline and up to 2 years]

      Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Written informed consent

    • Able to complete a PET/CT scan without the use of sedation

    • Females:

    • Of childbearing potential must:

    • Not be nursing

    • Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT

    • Not of childbearing potential must be:

    • Physiologically postmenopausal (cessation of menses for more than 1 year)

    • Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)

    • Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent

    • Scheduled to begin therapy

    • The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)

    • Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)

    • No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week

    Exclusion Criteria:
    • Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration

    • Known sensitivity to 18F FSPG or components of the preparation

    • Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Medical Center Stanford California United States 94304

    Sponsors and Collaborators

    • Andrei Iagaru
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Andrei M Iagaru, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02599194
    Other Study ID Numbers:
    • IRB-31855
    • NCI-2015-01125
    • VARIMG0006
    • P30CA124435
    First Posted:
    Nov 6, 2015
    Last Update Posted:
    Jan 3, 2019
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 18F-FSPG and 18F-FDG Intragroup Comparision
    Arm/Group Description Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
    Period Title: Overall Study
    STARTED 7
    COMPLETED 7
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title 18F-FSPG and 18F-FDG Intragroup Comparision
    Arm/Group Description Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
    Overall Participants 7
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    2
    28.6%
    >=65 years
    5
    71.4%
    Age (years) [Median (Standard Deviation) ]
    Median (Standard Deviation) [years]
    69.1
    (13.2)
    Sex: Female, Male (Count of Participants)
    Female
    3
    42.9%
    Male
    4
    57.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    7
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    2
    28.6%
    White
    5
    71.4%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    7
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
    Description Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
    Time Frame Baseline and up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis "mean of differences" would have a dispersion, but an analysis for "difference of means" is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion.
    Arm/Group Title 18F-FSPG and 18F-FDG Intragroup Comparision
    Arm/Group Description Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
    Measure Participants 7
    Measure Lesion locations assessed 40
    18F-FSPG
    -1.69
    18F-FDG
    -0.64
    2. Secondary Outcome
    Title Number of Treatment-Related Adverse Events
    Description Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
    Time Frame Baseline to up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 18F-FSPG and 18F-FDG Intragroup Comparision
    Arm/Group Description Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
    Measure Participants 7
    18F-FSPG
    0
    18F-FDG
    0
    3. Secondary Outcome
    Title Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
    Description Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
    Time Frame Baseline and up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). Lesions detected at either before or after treatment only are reported as the difference from zero.
    Arm/Group Title Difference in Lesion Size as Detected by 18F-FSPG Difference in Lesion Size as Detected by 18F-FDG
    Arm/Group Description Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV)
    Measure Participants 7 7
    Measure Lesion locations assessed 17 26
    Adrenal / adrenal mass, left
    NA
    11.3
    Adrenal / hepatic dome
    NA
    -2.0
    Adrenal / liver metastatis
    NA
    -1.3
    Adrenal / lung base metastatis, lower lobe right
    NA
    1.4
    Adrenal / lung metastatis, left
    NA
    -0.7
    Lung / infrascapular subcut
    0.2
    NA
    Lung / abdominal wall, upper quadrant right
    7.6
    6.9
    Lung / adajcent subcarinal lymph node
    NA
    3.0
    Lung / aortopulmonary window lymph node
    -1.1
    -2.8
    Lung / hilar lymph node, left
    NA
    -2.3
    Lung / infraspinatus mm, right
    10.4
    10.2
    Lung / lingula nodule
    -1.7
    -2.7
    Lung / mass, upper lobe left
    -8.1
    -6.4
    Lung / mass, lower lobe right
    NA
    -14.5
    Lung / nodule 1, lower lobe right
    NA
    -0.8
    Lung / nodule 2, upper lobe right
    -1.7
    -1.5
    Lung / nodule, upper lobe right
    NA
    -0.4
    Lung / paraesophageal lymph node
    0.9
    NA
    Lung / post-basal, lower lobe right
    NA
    -3.6
    Lung / subcarinal lymph node
    1.4
    11.4
    Renal / adrenal mass, right
    3.1
    7.1
    Renal / aortopulmonary window lymph node, left
    1.1
    -1.2
    Renal / gluteal subcutaneous nodule
    0.2
    0.2
    Renal / interlobar
    2.4
    NA
    Renal / kidney midpole, right
    -1.2
    -1.4
    Renal / omental nodule
    -0.2
    1.2
    Renal / paratracheal lymph node, right
    0.6
    -2.0
    Renal / parotid, right
    NA
    -2.3
    Renal / retroperitoneal lymph node, left
    1.6
    2.2

    Adverse Events

    Time Frame 30 days
    Adverse Event Reporting Description
    Arm/Group Title 18F-FSPG and 18F-FDG Intragroup Comparision
    Arm/Group Description Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV)
    All Cause Mortality
    18F-FSPG and 18F-FDG Intragroup Comparision
    Affected / at Risk (%) # Events
    Total 0/7 (0%)
    Serious Adverse Events
    18F-FSPG and 18F-FDG Intragroup Comparision
    Affected / at Risk (%) # Events
    Total 0/7 (0%)
    Other (Not Including Serious) Adverse Events
    18F-FSPG and 18F-FDG Intragroup Comparision
    Affected / at Risk (%) # Events
    Total 1/7 (14.3%)
    Metabolism and nutrition disorders
    Elevated blood ammonia 1/7 (14.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Andrei H. Iagaru
    Organization Stanford University
    Phone (650) 725-4711
    Email aiagaru@stanford.edu
    Responsible Party:
    Andrei Iagaru, Associate Professor of Radiology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT02599194
    Other Study ID Numbers:
    • IRB-31855
    • NCI-2015-01125
    • VARIMG0006
    • P30CA124435
    First Posted:
    Nov 6, 2015
    Last Update Posted:
    Jan 3, 2019
    Last Verified:
    Dec 1, 2018