Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04438304
Other study ID # CLS07
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 2, 2021
Est. completion date October 2024

Study information

Verified date May 2024
Source Clarity Pharmaceuticals Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic (GEP) Neuroendocrine Tumors (NETs) as a potential new way to help diagnose NETs.


Description:

Up to 63 participants will be recruited in this study and who are confirmed or suspected to have NETs based on biochemical evidence or that of conventional anatomical or molecular imaging.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 63
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent; 2. Age at enrolment = 18 years; 3. Life expectancy = 12 weeks; 4. Known diagnosis of GEP NET or suspicion of GEP NET based on axial imaging (e.g. on CT and/or MRI and/or FDG) and/or biochemical evidence of NET; 5. Adequate recovery from acute toxic effects of any prior therapy; 6. Adequate renal function (eGFR >30 ml/min); 7. Pre-study 68Ga-DOTATATE PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SARTATE; Exclusion Criteria: 1. Female participant who are pregnant or lactating; 2. Male or female participant of childbearing potential not willing to practice an effective method of birth control while participating on the study to avoid possible damage to the foetus. Abstinence is considered acceptable; 3. Participant has received any treatment (including experimental treatment) for their NET in the interval between 68Ga-DOTATATE PET/CT and 64Cu SARTATE PET/CT scan; 4. Any serious medical condition or extenuating circumstance which the investigator believes may interfere with the procedures or evaluations of the study; 5. History of other active malignancy within the last 2 years the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone therapy (patients may continue hormone therapy while on study). 6. Active oncologic therapy within 8 weeks prior to the 68GaDOTATATE PET/CT scan (long-acting somatostatin analogues are permitted and not considered active oncological treatment); 7. Participants with diffuse or infiltrative hepatic involvement based on the pre-study 68Ga-DOTATATE PET/CT scan; 8. Participants with extensive marrow/skeletal involvement (>20 lesions) based on the pre-study 68Ga-DOTATATE PET/CT scan.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
64Cu-SARTATE
64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 60µg.

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Nepean Hospital Kingswood New South Wales
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Royal North Shore Hospital Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Clarity Pharmaceuticals Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings Sensitivity and specificity on the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. At 4 hours post administration of 64Cu-SARTATE
Primary Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings Sensitivity and Specificity on the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. At 20 hours post administration of 64Cu-SARTATE
Primary Comparison of diagnostic performance of 64Cu-SARTATE to that of 68Ga-DOTATATE on a per-lesion basis for discordant findings Lesion detection rate on composite of 4-hour and 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT. At 4 and 20 hours post administration of 64Cu-SARTATE
Primary To assess the proportion of concordance between 4-hour 64Cu-SARTATE to that of 68Ga-DOTATATE Concordance measured on a per-lesion basis At 4 hours post administration of 64Cu-SARTATE
Secondary To compare the diagnostic performance of 64Cu-SARTATE to 68Ga-DOTATATE on a per-participant basis in participants with suspected disease only. Sensitivity and specificity of the 4-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
Sensitivity and specificity of the 20-hour 64Cu-SARTATE PET/CT compared to 68Ga-DOTATATE PET/CT.
At 4 hours and 20 hours post administration of 64Cu-SARTATE
Secondary Incidence of adverse events related to 64Cu-SARTATE Adverse events will be graded using the national cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 week post administration of 64Cu-SARTATE
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 NCT02132468 - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers Phase 2
Completed NCT02134639 - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation N/A
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