Clinical trial · Interventional
Gallium 68 Pentixafor in Patients With Neuroendocrine Tumors
Biodistribution of Ga-68 Pentixafor in Patients With Neuroendocrine Tumors
NCT03335670CI-TRIAL-00092077active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Pentixafor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Pentixafor PET scan
- description
- 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.
- interventionNames
- Drug: [68Ga]Pentixafor
Primary outcomes (2)
- measure
- Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs)
- timeFrame
- Within 1 month of [68Ga]Pentixafor scan
- description
- 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.
- measure
- Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDLapa 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. PMID 26909116
- BACKGROUNDBluemel 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. PMID 27819856
- BACKGROUNDHerhaus 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. PMID 27175029