Efficacy and safety of a new tracer for urologic tumors
- Conditions
- Genitourinary tract tumors in male patientsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000940-17-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 20
1. Over 18 y/o patients at enrolling;
2. Patient afflicted with kidney, bladder or penis neoplasm elegible for demolitive surgery;
3. Histologically documented prostate cancer afflicted patients, in treatment with ADT (orchiectomy and/or LHRH agonists and/or androgen antagonists); patients with diagnosis of metastatic prostate cancer, detectable at re-staging TC scan too; recent disease progression (serial PSA increasing and/or clinical or radiological progression), under ADT, with clinical indication to restaging, even radiological.
4. Availability of a re-staging whole body CT scan (with and without contrast media) executed in 20 days prior to the enrollement (slice thickness < 5mm);
5. Availability of:
- re-staging whole body CT scan (with and without contrast media) executed 8 months prior to the enrollement visit (slice thickness < 5mm);
- At least one of the following functional and metabolism imaging exams, executed as clinically indicated restaging, 20 days prior to the enrollement:
?MRI (ossea),
?18F-FCH PET/CT,
?99mTc-HDP (SPECT)
?18F-FDG PET/CT;
6. No clinical history of other neoplasms (previously or at time of the enrollement), execpt non-melanoma skin carcinomas.
7. Karnofski index >80%
8. Absence of relevant comorbidities
9. Plain fitness to plead all the informations given in the Subject Illustration Documentation.
10. Plain fitness to subscribe an effective informd consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Anemia (Hb<10 g/dL)
2.Presence of symptoms or signs of sepsis and/or acute infections
3.AST more than 1.5 times higher than normality range limit
4.ALT more than 1.5 times higher than normality range limit
5.total bilirubin more than 1.5 times higher than normality rage limit
6.Clinical History or analytic evidence of HBV infection
7.Clinical History or analytic evidence of HCV infection
8.KCD more severe than stage II (eGRF< 60 ml/min calculated with MDRD equation)
9.TIA or Ictus less than six months before enrollement
10.Diagnosis of neurodegenerative disease
11.Other chronic CNS diseases
12.Clinical history of psychiatric pathology or therapeutical usage of major psychopharmacological drugs
13.ACS less than six months before enrollement
14.heart failure NYHA>1 or LVEF< 50%, clinically documentable
15.Valvulopathy with indication to surgical correction
16.Chronic respiratory disease with significative functional limitiation
17.Cupper metabolism diseases
18.Diabetes Mellitus under insuline therapy
19.Subjects who have received Chemiotherapics
20.Subjects underwent radiotherapy in the 120 days before enrolling
21.Subjects underwent major srgery interventions in the 120 days before enrolling
22.BMI> 28
23.Previous partecipation to clinical trials involving exposure to ionizing radiations with therapeutical purposes.
24.Work related exposure to ionising radiations
25.Any material, logistical or subjective condition that, even in the opinion of the principle experimenter, could condition subject’s compliance to execution of any of the procedures expected by the protocol
26.Subject’s inhability to understand informative documentation content.
27.Pregnancy -? Mandatory negative pregnancy test for women in fertile age.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events).;Secondary Objective: 1) lesion-based sensitivity of whole body PET/TC scan after CuCl2 somministration in primary and metastatic lesions.<br>2) Techincal performance evaluation of CuCl2 PET/TC scan [target/background (T/B) contrast]<br>;Primary end point(s): Efficacy (sensibility patient based of total body PET/TC scan after CuCl2 somministration) and tradiotracer safety (based on assessment of frequency and features of possible adverse events).;Timepoint(s) of evaluation of this end point: 15 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) lesion-based sensitivity of whole body PET/TC scan after CuCl2 somministration in primary and metastatic lesions.<br>2) Techincal performance evaluation of CuCl2 PET/TC scan [target/background (T/B) contrast]<br>;Timepoint(s) of evaluation of this end point: 30 days