Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients With Neuroendocrine Neoplasms
Study Details
Study Description
Brief Summary
Prospective clinical trial investigating combined, dual 18F-FDG PET/CT and 64Cu-DOTATATE PET/CT imaging of patients with gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Patients with neuroendocrine neoplasms (NEN) represent a heterogeneous disease group with variable prognosis. NEN most frequently arise from the gastrointestinal tract or the pancreas; collectively termed GEP-NEN. Grading of GEP-NEN is based on tumor proliferation index (Ki-67) from biopsies or surgical resection specimens into: low grade G1 neuroendocrine tumor (NET) (Ki-67<3%), intermediate grade G2 NET (Ki-67 3-20%) and high grade NEN (Ki-67%>20). High grade NENs are further categorized according to tissue morphology into well-differentiated G3 neuroendocrine tumors (NET) and poorly differentiated neuroendocrine carcinomas (NEC).
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Each patient will undergo one standard of care 18FDG PET/CT and one 64Cu-DOTATATE PET/CT within 4 weeks. |
Drug: 18F-FDG
PET/CT scan approximately 60 min after injection of 18F-FDG
Other Names:
Drug: 64Cu-Dotatate
PET/CT scan approximately 60 min after injection of 64Cu-Dotatate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [12 months after last-patients-last-visit]
Time to disease progression from PET/CT scans. Disease progression is defined as a composite measure (whichever occurs first) of RECIST-1.1 defined radiological progression, commencement of another systemic therapy and/or surgery/embolization/ablation related to worsening to the patient's disease status after the index scan, progression evaluated by a multidisciplinary tumor board, and death related to the patient's NEN disease. In case of uncertainty if progression has occurred, the patient's disease status will be evaluated by a multidisciplinary tumor board.
Secondary Outcome Measures
- Overall survival (OS) [12 months after last-patients-last-visit]
Time to death from PET/CT scans.
- Correlation between tumor standardized uptake values (SUV) on 18F-FDG PET and 64Cu-DOTATATE PET [12 months after last-patients-last-visit]
SUV measured on matched tumors on 18F-FDG PET and 64Cu-DOTATATE PET are compared
- Proportion of patients eligible for peptide receptor radionuclide therapy (PRRT) [12 months after last-patients-last-visit]
The proportion of patients who are considered eligible for PRRT based on their 64Cu-DOTATATE PET/CT according to the routine clinical guidelines at the department
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histopathologically verified gastro-entero-pancreatic neuroendocrine neoplasm (GEP-NEN) or patients with unknown primary tumor with metastases with verified NEN positive histopathological examination suggesting GEP origin
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World Health Organization (WHO) Performance status 0-2
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Must be able to read and understand the patient information in Danish and to give informed consent
Exclusion Criteria:
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Pregnancy
-
Breast-feeding
-
Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
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Uncontrolled diabetes
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Uncontrolled infection
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Exacerbation in autoimmune diseases
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Other active cancer disease
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Conditions or diseases (e.g. uncontrolled Parkinson's disease) making the patient unable to lie still in the scanner
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Severe claustrophobia
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Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach
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History of allergic reaction attributable to compounds of similar chemical or biologic com-position to 18FDG or 64Cu-DOTATATE
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Study Director: Andreas Kjaer, MD, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK_NEN_DOTA-FDG_21