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
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: [68Ga]Pentixafor||Early Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor
Other Name: (68Ga)pentixafor
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335670
|Contact: Veronica Howsare, AA, MA||(319) email@example.com|
|Contact: Kristin Gaimari-Varner, RN, BSN||(319) firstname.lastname@example.org|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Veronica Howsare, AA, MA email@example.com|
|Contact: Kristin Gaimari-Varner, RN, BSN (319) 384-5489 firstname.lastname@example.org|
|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|
|Principal Investigator:||Yusuf Menda, MD||University of Iowa|
|Principal Investigator:||M. Sue O'Dorisio, MD, PhD||University of Iowa|