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Trial record 18 of 2712 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: [68Ga]Pentixafor Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: [68Ga]Pentixafor
68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor
Other Name: (68Ga)pentixafor




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335670


Contacts
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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

Locations
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United States, Iowa
Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Veronica Howsare, AA, MA       veronica-howsare@uiowa.edu   
Contact: Kristin Gaimari-Varner, RN, BSN    (319) 384-5489    kristin-gaimari-varner@uiowa.edu   
Principal Investigator: Yusuf Menda, MD         
Principal Investigator: M. S. O'Dorisio, MD, PhD         
Sub-Investigator: Gideon Zamba, PhD         
Sub-Investigator: Andrew Bellizzi, MD         
Sub-Investigator: Daniel Berg, MD         
Sub-Investigator: David Bushnell, MD         
Sub-Investigator: Chandrikha Chandrasekharan, MD         
Sub-Investigator: David Dick, PhD         
Sub-Investigator: Joseph Dillon, MD         
Sub-Investigator: Lisa Dunnwald, MPH         
Sub-Investigator: Kristin Gaimari-Varner, RN, BSN         
Sub-Investigator: Silvia Ghobrial, MD         
Sub-Investigator: Michael M. Graham, MD, PhD         
Sub-Investigator: Veronica Howsare, AA, MA         
Sub-Investigator: Shannon Lehman, BA         
Sub-Investigator: Thomas O'Dorisio, MD         
Sub-Investigator: Janet Pollard, MD         
Sub-Investigator: Laura Ponto, PhD         
Sub-Investigator: Mary Schall, RN, BSN         
Sub-Investigator: John Sunderland, PhD         
Sponsors and Collaborators
Yusuf Menda
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
Investigators
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Principal Investigator: Yusuf Menda, MD University of Iowa
Principal Investigator: M. Sue O'Dorisio, MD, PhD University of Iowa

Publications:
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Responsible Party: Yusuf Menda, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03335670     History of Changes
Other Study ID Numbers: 201708705
P50CA174521 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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.

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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

Keywords provided by Yusuf Menda, University of Iowa:
68Ga-pentixafor
(68Ga)pentixafor
Gallium Radioisotopes
CXCR4

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue