Diagnostic value of 64CuCl2-PET/MRI in prostate cancer relapse.

Diagnostic and clinical value of fused 64CuCl2-PET/MRI in prostate cancer relapse. Comparison with multiparametric MRI (mMRI) and 18F-Choline-PET/MRI - Diagnostic and clinical value of 64CuCl2-PET/MRI in prostate cancer relapse.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005140-18-IT

Enrollment

Registered

2018-01-08

Start date

2015-11-12

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy MedDRA version: 20.0 Level: SOC Classification code 10038604 Term: Reproductive system and breast disorders System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Product Code: 64CuCl2 Pharmaceutical Form: Solution for infusion CAS Number: 7447-39-4 Current Sponsor code: RAME 01 Concentration unit: MBq/µl megabecquerel(s)/microlitre Concentration type: equal Co

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -years > 18 (no upper age limit) -all histologically proven prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy -Gleason score =6, -increasing levels of PSA and PSA doubling time (DT) =6 months. -Informed consent available Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: -comorbidity for other neoplasms -inability to perform MRI -known hypersensitivity to the substances or excipients contained in the tracers and contrast agent

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study was firstly to assess the diagnostic performance of fused 64CuCl2-PET/MRI in patients with suspected relapse of prostate cancer after surgery or EBRT. In addition we want to compare the accuracy of fused 64CuCl2-PET/MRI with that of mMRI,18F-Choline-PET/MRI, 18F-Choline-PET/CT, and contrast enhanced CT in detecting local recurrence, lymph node, and bone metastases;Secondary Objective: Secondary objectives: -to assess whether 64CuCl2-PET/MRI could eventually influence patient management, treatment decisions and outcome in comparison with all available data. Of course all patients will be followed up and treated independently by 64CuCl2-PET/MRI results; -to test the association between 64CuCl2-PET/MRI detection rate, PSA level and Gleason score; -to assess the association between the standard uptake value (SUV-max) of 64CuCl2-PET and apparent diffusion coefficient (ADC) value of local recurrence and lymph node metastases; -To assess and compare the diagnostic performance of 3 further acquisitions of 64CuCl2 PET/CT; -To acquire new information and refine the safety profile of 64CuCl2 for the execution of PET/CT diagnostics; -To study the kinetic profile of 64CuCl2. ;Primary end point(s): The primary end point is to evaluate the accuracy defined as: (True Negative + True Positive)/(True Negative + True Positive + False Negative + False Positive) = (Number of correct assessments)/Number of all assessments).;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The aim of this study was firstly to assess the diagnostic performance of fused 64CuCl2-PET/MRI in patients with suspected relapse of prostate cancer after surgery or EBRT. In addition we want to compare the accuracy of fused 64CuCl2-PET/MRI with that of mMRI,18F-Choline-PET/MRI, 18F-Choline-PET/CT, and contrast enhanced CT in detecting local recurrence, lymph node, and bone metastases;Secondary Objective: Secondary objectives: -to assess whether 64CuCl2-PET/MRI could eventually influence patient management, treatment decisions and outcome in comparison with all available data. Of course all patients will be followed up and treated independently by 64CuCl2-PET/MRI results; -to test the association between 64CuCl2-PET/MRI detection rate, PSA level and Gleason score; -to assess the association between the standard uptake value (SUV-max) of 64CuCl2-PET and apparent diffusion coefficient (ADC) value of local recurrence and lymph node metastases; -To assess and compare the diagnostic performance of 3 further acquisitions of 64CuCl2 PET/CT; -To acquire new information and refine the safety profile of 64CuCl2 for the execution of PET/CT diagnostics; -To study the kinetic profile of 64CuCl2. ;Primary end point(s): The primary end point is to evaluate the accuracy defined as: (True Negative + True Positive)/(True Negative + True Positive + False Negative + False Positive) = (Number of correct assessments)/Number of all assessments).;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. The secondary end point is to evaluate the specificity defined as: True Negative/(True Negative + False Positive) = (Number of true negative assessment)/(Number of all negative assessment) 2. The secondary end point is to evaluate the positive predictive value (PPV) defined as: True positive/(True positive+ False positive). 3. The secondary end point is to evaluate the negative predictive value (NPV) defined as: True negative/(True negative+ False negative). 4. The secondary end point is to evaluate the sensitivity defined as: True Positive/(True Positive + False Negative) = (Number of true positive assessment)/(Number of all positive assessment) 5. Assess and compare the sensitivity, specificity, PPV, NPV and accuracy as defined above, considering further PET / CT exams performed after 4 and 24 hours from baseline 6. Safety endpoints will be: blood pressure, heart and respiratory rate, signs and symptoms, blood tests (blood count, C-reactive protein, transaminases and gamma GT, ALP, creatinine and nitrogen) and glucose by glucometer. 7. kinetics endpoints will be: - The absorbed dose by determining the volume of interest (VOI) of the relevant internal body areas using co-registered PET / CT images at 90 minutes and at 4 and 24 hours from injection. - The masses and the cumulative activity for the internal body areas involved.;Timepoint(s) of evaluation of this end point: 1. 12 months 2. 12 months 3. 12 months 4. 12 months 5. 12 months 6. baseline, 7 and 24 hours after the first IMP administration 7. 90 minutes, 4 and 24 hours from injection.	—

Measure

Time frame

Secondary end point(s): 1. The secondary end point is to evaluate the specificity defined as: True Negative/(True Negative + False Positive) = (Number of true negative assessment)/(Number of all negative assessment) 2. The secondary end point is to evaluate the positive predictive value (PPV) defined as: True positive/(True positive+ False positive). 3. The secondary end point is to evaluate the negative predictive value (NPV) defined as: True negative/(True negative+ False negative). 4. The secondary end point is to evaluate the sensitivity defined as: True Positive/(True Positive + False Negative) = (Number of true positive assessment)/(Number of all positive assessment) 5. Assess and compare the sensitivity, specificity, PPV, NPV and accuracy as defined above, considering further PET / CT exams performed after 4 and 24 hours from baseline 6. Safety endpoints will be: blood pressure, heart and respiratory rate, signs and symptoms, blood tests (blood count, C-reactive protein, transaminases and gamma GT, ALP, creatinine and nitrogen) and glucose by glucometer. 7. kinetics endpoints will be: - The absorbed dose by determining the volume of interest (VOI) of the relevant internal body areas using co-registered PET / CT images at 90 minutes and at 4 and 24 hours from injection. - The masses and the cumulative activity for the internal body areas involved.;Timepoint(s) of evaluation of this end point: 1. 12 months 2. 12 months 3. 12 months 4. 12 months 5. 12 months 6. baseline, 7 and 24 hours after the first IMP administration 7. 90 minutes, 4 and 24 hours from injection.

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Countries

Italy

Contacts

Public ContactUfficio del Coordinatore Scientific

E.O.Ospedali Galliera - Genova

ucs@galliera.it0105634228

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026