Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms
NCT ID: NCT05709171
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
200 participants
INTERVENTIONAL
2023-01-17
2026-01-01
Brief Summary
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Detailed Description
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A common feature of most NETs is the overexpression of somatostatin receptors (SSR) on the tumor cell surface. Whole-body PET/CT imaging with radiolabelled SSR-targeted tracers, e.g. 64Cu-DOTATATE, plays a key role in diagnosis, staging, treatment selection and response evaluation of patients with NET. Measurements of 64Cu-DOTATATE tumor standardized uptake values (SUV) and tumor volume on PET/CT provide prognostic value for patients with NET. Patients with high grade NEN often have lower SSR expression and SSR PET/CT is infrequently routinely performed in these patients. However, we expect that the SUV and tumor volume from 64Cu-DOTATATE PET/CT also holds prognostic information for patients with high grade NEN and that some patients may prove eligible for PRRT based on the scans.
18F-FDG PET/CT imaging is widely used in cancers, but is routinely primarily reserved for patients with high grade NEN. However, 18F-FDG PET/CT also holds prognostic information for patients with lower grade NET.
By combining 64Cu-DOTATATE PET/CT and 18F-FDG PET/CT imaging, we expect to obtain complementary prognostic information for patients with GEP-NEN of all grades. In this clinical trial, we will therefore investigate and compare the tumor phenotypes found on 64Cu-DOTATATE PET/CT and 18FDG PET/CT performed within 4 weeks in patients with GEP-NET G1-3 and GEP-NEC. The aim of the trial is to establish prognostic models for progression-free-survival (PSF) and overall survival (OS) including tumor status (positive/negative), SUV measurements, and tumor volume derived from the dual 64Cu-DOTATATE PET/CT and 18FDG PET/CT scans.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Experimental
Each patient will undergo one standard of care 18FDG PET/CT and one 64Cu-DOTATATE PET/CT within 4 weeks.
18F-FDG
PET/CT scan approximately 60 min after injection of 18F-FDG
64Cu-Dotatate
PET/CT scan approximately 60 min after injection of 64Cu-Dotatate
Interventions
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18F-FDG
PET/CT scan approximately 60 min after injection of 18F-FDG
64Cu-Dotatate
PET/CT scan approximately 60 min after injection of 64Cu-Dotatate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* World Health Organization (WHO) Performance status 0-2
* Must be able to read and understand the patient information in Danish and to give informed consent
Exclusion Criteria
* Breast-feeding
* Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
* Uncontrolled diabetes
* Uncontrolled infection
* Exacerbation in autoimmune diseases
* Other active cancer disease
* Conditions or diseases (e.g. uncontrolled Parkinson's disease) making the patient unable to lie still in the scanner
* Severe claustrophobia
* Localized neuroendocrine neoplasms of the appendix, the rectum measuring \< 1 cm, and ECL-omas of the stomach
* History of allergic reaction attributable to compounds of similar chemical or biologic com-position to 18FDG or 64Cu-DOTATATE
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Mathias Loft
MD
Principal Investigators
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Andreas Kjaer, MD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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AK_NEN_DOTA-FDG_21
Identifier Type: -
Identifier Source: org_study_id