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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA174521 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
| Holden Comprehensive Cancer Center | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]Pentixafor PET scan | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Pentixafor | Drug | 68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs) | 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. | Within 1 month of [68Ga]Pentixafor scan |
| Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions | Determine the difference, in any, of the biodistribution values between scans 1 and 2, for subjects who undergo 2 [68Ga]Pentixafor scans. | Within 1 month of the second [68Ga]Pentixafor scan |
| Measure | Description | Time Frame |
|---|---|---|
| Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions | 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). | Within 6 months of [68Ga]Pentixafor scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuf Menda, MD | University of Iowa | Principal Investigator |
| M. Sue O'Dorisio, MD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26909116 | Background | Lapa C, Luckerath K, Kleinlein I, Monoranu CM, Linsenmann T, Kessler AF, Rudelius M, Kropf S, Buck AK, Ernestus RI, Wester HJ, Lohr M, Herrmann K. (68)Ga-Pentixafor-PET/CT for Imaging of Chemokine Receptor 4 Expression in Glioblastoma. Theranostics. 2016 Jan 25;6(3):428-34. doi: 10.7150/thno.13986. eCollection 2016. | |
| 27819856 | Background | Bluemel C, Hahner S, Heinze B, Fassnacht M, Kroiss M, Bley TA, Wester HJ, Kropf S, Lapa C, Schirbel A, Buck AK, Herrmann K. Investigating the Chemokine Receptor 4 as Potential Theranostic Target in Adrenocortical Cancer Patients. Clin Nucl Med. 2017 Jan;42(1):e29-e34. doi: 10.1097/RLU.0000000000001435. |
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Individual participant data will be shared upon request to the study's principal investigator. A signed usage agreement will need to be provided.
After the study has been completed.
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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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000597686 | 68Ga-pentixafor |
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| 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. |
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) |
| Within 6 months of [68Ga]Pentixafor scan |
| 27175029 | Background | Herhaus P, Habringer S, Philipp-Abbrederis K, Vag T, Gerngross C, Schottelius M, Slotta-Huspenina J, Steiger K, Altmann T, Weisser T, Steidle S, Schick M, Jacobs L, Slawska J, Muller-Thomas C, Verbeek M, Subklewe M, Peschel C, Wester HJ, Schwaiger M, Gotze K, Keller U. Targeted positron emission tomography imaging of CXCR4 expression in patients with acute myeloid leukemia. Haematologica. 2016 Aug;101(8):932-40. doi: 10.3324/haematol.2016.142976. Epub 2016 May 12. |
| D009380 | Neoplasms, Nerve Tissue |