Clinical Trials Logo
  1. Home
  2. Neuroendocrine Tumors
  3. NCT03278275
  4. Details
NCT03278275 Clinical Trial

PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

Neuroendocrine Tumors Clinical Trial

Official title:
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03278275
Other study ID # AK2017-1
Secondary ID 2017-002312-13
Status Completed
Phase Phase 2
First received
Last updated
Start date November 1, 2017
Est. completion date July 8, 2021

Study information
Verified date June 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).

Description:

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date July 8, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET. - WHO performance status 0-2 - Must be able to read and understand the patient information in Danish and to give informed consent Exclusion Criteria: - Pregnancy - Breast-feeding - Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg) - History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E[c(RGDyK)]2 - In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• One injection of 68Ga-NOTA-AE105
One injection of 68Ga-NORA-AE105
Device:
• PET/CT
Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT

Locations
Country Name City State
Denmark Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary uPAR PET/CT imaging of patients with neuroendocrine tumors The radioligand 68Ga-NOTA-AE105 can be used to visualize neuroendocrine tumors (grade G1-G3) 1 hour
Secondary uPAR PET/CT prognostic factor for progression free survival The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with progression free survival (PFS) neuroendocrine tumors (grade G1-G3) 12 months
Secondary uPAR PET/CT prognostic factor for overall and disease specific survival The uptake of the 68Ga-NOTA-AE105 in neuroendocrine tumor lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine tumors (grade G1-G3) 12 months
See also
  Status Clinical Trial Phase
Completed NCT01218555 - Study of Everolimus (RAD001) in Combination With Lenalidomide Phase 1
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Withdrawn NCT04614766 - A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors Phase 1/Phase 2
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT05636618 - Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors Phase 1/Phase 2
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT02815969 - The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02174549 - Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer Phase 1/Phase 2
Completed NCT02134639 - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation N/A
Completed NCT02132468 - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers Phase 2
Recruiting NCT01201096 - Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE) N/A
Terminated NCT01163526 - Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies N/A
Completed NCT01099228 - Combination Targeted Radiotherapy in Neuroendocrine Tumors N/A
Completed NCT00171873 - Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut Phase 3
Active, not recruiting NCT05077384 - Open-label Study of Surufatinib in Japanese Patients Phase 1/Phase 2
Active, not recruiting NCT04544098 - Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver Early Phase 1
Active, not recruiting NCT02736500 - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors Phase 1/Phase 2