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Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT03335670
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Yusuf Menda, University of Iowa

Tracking Information
First Submitted Date  ICMJE October 12, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date April 4, 2019
Actual Study Start Date  ICMJE November 3, 2017
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs) [ Time Frame: Within 1 month of [68Ga]Pentixafor scan ]
    Biodistribution will be assessed through the radiotracer parameters standardized uptake value (SUV) and K-influx obtained from PET scan and blood samples.These values provide a pharmacokinetic profile of the investigational drug's biodistribution in the body.
  • Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions [ Time Frame: Within 1 month of the second [68Ga]Pentixafor scan ]
    Determine the difference, in any, of the biodistribution values between scans 1 and 2, for subjects who undergo 2 [68Ga]Pentixafor scans.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Investigate the biodistribution of 68Ga Pentixafor in patients with neuroendocrine tumors [ Time Frame: Following scan-1 through study completion, an average of two years ]
    The primary outcome for the biodistribution investigation will be (1) the uptake of 68Ga Pentixafor in normal organs and tumor and (2) the kinetics of tumor uptake of 68Ga Pentixafor in tumors. The uptake in normal organs and tumors will be measured using standardized uptake value (SUV in g/ml). The kinetics will be investigated on dynamic images and the influx rate of 68Ga-Pentixafor into the tumor (K-influx in ml/g/min) will be measured. For the biodistribution, point estimates will be generated and exact confidence intervals constructed around SUV and K-influx within each grade category. Means and medians SUV and K-influx will be compared across various grades. Means, standard deviations, medians and interquartile range and confidence intervals for differences in uptake will also be reported. Exact nonparametric techniques will be employed for equality of medians or means and exact confidence intervals will be reported.
  • Investigate the repeatability of 68Ga Pentixafor uptake in NET lesions [ Time Frame: Following scan-1 through study completion, an average of two years ]
    To assess repeatability, SUV and K-influx parameters will be compared between baseline scan and repeat scan (1-10 days after baseline scan) to evaluate the extent of reproducibility. The difference between the two scans for SUV and K-influx will be calculated by percent difference and absolute percent difference. As a measure of reproducibility, intraclass correlation coefficient (ICC) will be calculated between the SUV and K-influx values obtained at baseline and follow-up scan.
Change History Complete list of historical versions of study NCT03335670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions [ Time Frame: Within 6 months of [68Ga]Pentixafor scan ]
    The standardized uptake value (SUV) of known neuroendocrine tumors for the investigational agent [68Ga]Pentixafor will be compared to the SUV for [68Ga]DOTATATE (NetSpot).
  • Correlate the uptake of [68Ga]Pentixafor and [68Ga]DOTATATE (NetSpot) in known neuroendocrine tumor lesions with expression of receptors (CXCR4 and SSTR2) in biopsy tissue samples. [ Time Frame: Within 6 months of [68Ga]Pentixafor scan ]
    The standardized uptake value (SUV) of the gallium PET tracers ( [68Ga]Pentixafor and/or [68Ga]DOTATATE) will be compared to the receptor expression score (H-score)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Compare the uptake of 68Ga Pentixafor and 68Ga DOTATATE in NET lesions [ Time Frame: Following scan-1 through study completion, an average of two years ]
    The SUV of tumors and normal organs on Ga-68 Pentixafor will be compared to SUV on Ga-68 DOTATATE.
  • Correlate the in vivo uptake of 68Ga Pentixafor and 68Ga DOTATATE in neuro-endocrine tumors (NET) with tissue expression of CXCR4 and SSTR2 using immunohistochemistry [ Time Frame: Following scan-1 through study completion, an average of two years ]
    As a correlative study, the tumor uptake of Ga-68 DOTATATE and Ga-68 Pentixafor scans (quantified using SUV) will be correlated with the immunohistochemistry for somatostatin receptor and CXCR4 in available tumor tissue material from each subject in the study (quantified using the hormone receptor score [H-score]).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors
Official Title  ICMJE Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors
Brief Summary This study will evaluate how Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated scans. This is an RDRC study - as such, the images obtained for this study cannot be used clinically or shared with treating oncologists.
Detailed Description

High grade neuroendocrine tumors often do not express somatostatin (sstr) receptors but often express the CXCR4 receptor. The CXCR4 receptor is a marker of poorly differentiated cells. Pentixafor is a peptide that targets these CXCR4 receptors. By combining it with gallium-68, a radionuclide, pentixafor can then be evaluated as an imaging agent to detect high-grade neuroendocrine tumors.

[68Ga]Pentixafor is a radio-labelled imaging agent used for positron emission tomography (PET). The dose is small, known as a tracer dose. It is designed to capture information about the body and how the body is working without interfering or causing an effect.

The goal of this study is to evaluate how the [68Ga]Pentixafor is distributed through the body after injection and how it is taken up by the organs of the body. The study will also examine if the imaging is reproducible to determine if the PET images show the same uptake of the study drug across different scans.

This study is an RDRC study - the equivalent to a phase 0 study. The [68Ga]Pentixafor has not been shown to target tumors; specificity and sensitivity have not been established. For this reason, images obtained for this study cannot be used clinically or shared with treating oncologists.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: [68Ga]Pentixafor
68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor
Other Name: (68Ga)pentixafor
Study Arms  ICMJE Experimental: [68Ga]Pentixafor PET scan
4 mCi (range 3-5 mCi) of [68Ga]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (~ 1 tsp) will be taken for pharmacokinetic analysis.
Intervention: Drug: [68Ga]Pentixafor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Histological diagnosis of neuroendocrine tumor (NET).
  3. Had a prior 68Ga DOTATATE PET/CT scan (NetSpot) and a CT or MRI with or without contrast performed within 3 months before signing the consent, without interval treatment other than a somatostatin analog.
  4. CT or MRI must demonstrate at least one lesion (primary or metastatic) present 1.5 cm or larger in any dimension on cross-sectional imaging (CT or MRI) obtained within 3 months of study enrollment.
  5. Results of CXCR4 immunohistochemistry or slides from biopsy of primary tumor or metastatic lesions available for study analysis.
  6. Participation in the Iowa Neuroendocrine Tumor Registry.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  2. Physical limitation that would limit compliance with the study requirements
  3. Pregnant or lactating women. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A negative pregnancy test will be required for all female subjects with child bearing potential.
  4. Planned administration of any NET therapy between scan 1 and 2, except for Somatostatin analog.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Veronica Howsare, AA, MA (319) 384-6469 veronica-howsare@uiowa.edu
Contact: Kristin Gaimari-Varner, RN, BSN (319) 384-5489 kristin-gaimari-varner@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335670
Other Study ID Numbers  ICMJE 201708705
P50CA174521 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After the study has been completed.
Access Criteria: Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.
Responsible Party Yusuf Menda, University of Iowa
Study Sponsor  ICMJE Yusuf Menda
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Holden Comprehensive Cancer Center
Investigators  ICMJE
Principal Investigator: Yusuf Menda, MD University of Iowa
Principal Investigator: M. Sue O'Dorisio, MD, PhD University of Iowa
PRS Account University of Iowa
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP