Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Day 1 of the Run-in a low dose of \[89Zr -Df-CriPec® docetaxel (corresponding to 0.1- 2 mg docetaxel). On Cycle 1 Day 1, the patients will receive unlabelled CriPec® docetaxel of a variable dose up to 60mg/m2 followed \< 2 h by a second low dose of \[89Zr\]-Df-CriPec® docetaxel. On day 1 of each subsequent cycle, patients will only receive unlabelled CriPec® docetaxel . The dose will be the same as was given on Cycle 1 Day 1. For the following patients the dose of unlabelled CriPec® docetaxel combined with the low dose of \[89Zr\]-Df- CriPec® docetaxel will be variable but never exceed the highest dose of unlabelled CriPec® docetaxel that was determined to be safe in the phase I NAPOLY trial (CT-CL01).

Cripec Docetaxel

A clinical phase I, open-label PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel.

After patient inclusion an fludeoxyglucose-18 (\[18F\]-FDG) PET scan will be performed to delineate viable tumour lesions. On day 1, patients will receive a low dose of \[89Zr\]-Df-CriPec® docetaxel (corresponding to approximately 0.1-1 mg docetaxel) followed by maximally 3 \[89Zr\] PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 h - 9 days after administration) to evaluate biodistribution and tumour uptake. Two weeks later, the patients will receive unlabelled CriPec® docetaxel up to the Recommended Phase II Dose (RP2D) given every 3 weeks (Q3W) that will be determined in the phase I NAPOLY trial (CT-CL01), immediately followed by a second low dose of \[89Zr\]-Df-CriPec® docetaxel and maximally 3 \[89Zr\]PET scans (timing of PET scan can be adapted depending on results obtained, within timeframe of 2 hrs - 9 days after administration) to evaluate biodistribution and tumour uptake with therapeutic dosage.

Phase I, open-label, single centre immune-PET study with \[89Zr\]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of \[89Zr\]-Df-CriPec® docetaxel

PET Study With [89Zr]-Df-CriPec® Docetaxel

A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel

Visual detection (absent/present) of tumor uptake

Measured by SUVpeak values of visual positive lesions

Based on 89Zr PK activity concentration (Bq/ml) and biodistribution \[89Zr\]-Df-CriPec® docetaxel scans

Assessment of 89Zr PK (Bq/ml) and total docetaxel (ng/ml)

Measured by defining volumes of interest (VOI) of various organs on PET scan and calculating %ID/kg

Cristal Therapeutics

Amsterdam UMC, location VUmc

Principal Investigator

Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in routine practice. The aim of this study is to assess the prognostic interest of quantitative bone SPECT-CT in BMPC.

Prostate adenocarcinoma is one of the most common cancer in men, and bone its most frequent distant metastasis location. 5-year survival has greatly increased these last two decades, with wide differences between countries. Nevertheless, the prognosis of castrate-resistant bone metastatic prostate cancer (BMPC) remains poor.

PCWG (Prostate Cancer Working Group) 2 has proposed in 2007 criteria to evaluate response to treatment for prostate cancer. There are based on composite data, including clinical signs (such as general condition and bone pain), Prostatic Specific Antigen (PSA) variation, CT scan (RECIST criteria) and bone scan. The scintigraphic part is based on whole body planar acquisition, and on the assessment of new uptakes. These bone scan criteria are simplistic, because only a visual analysis is possible, without consideration of changes in intensity. Moreover, these criteria consider the bone scan as a planar imaging, and it has been shown that Single Photon Emission Computed Tomography (SPECT) improved sensitivity, specificity, positive and negative predictive values in oncologic context. Finally, "PCWG2 (Prostate Cancer Working Group 2) recognizes that there are no validated criteria for response on radionuclide bone scan".

To reflect bone metastasis burden, a quantitative analysis method for bone scintigraphy, the Bone Scan Index (BSI), had been tested. BSI is based on the uptake of whole body planar imaging. While baseline BSI seemed to offer a poor correlation with overall survival (OS), on-treatment changes in BSI appeared to be a decent response marker. But a volumetric quantitative biomarker may improve the accuracy of this assessment.

The recent development of a new SPECT quantification tool (xSPECT Quant® tool, Siemens) could offer good performances on therapeutic assessment. The objective of this study is to assess the interest of this new quantitative volumetric method in bone scan response evaluation of BMPC.

Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma

Assessment of prognostic quantitative SPECT-CT parameters

Assessment of correlation between baseline PSA and baseline quantitative SPECT-CT parameters (SUVmax (max Standardized Uptake Value) of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)

Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and baseline quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)

Assessment of correlation between variations of PSA and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism) (Spearman coefficient)

Assessment of correlation between survival (Progression Free Survival, Overall Survival, Disease Specific Survival) and variations of quantitative SPECT-CT parameters (SUVmax of the target lesions, SUVpeak of the highest uptake lesion, Neoplastic Osteoblastic Metabolism Volume, Total Lesion Osteoblastic Metabolism)

University Hospital, Brest

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Hematinics

Liver Extracts

Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (SUVmax and SUVpeak) and uptake volume (UV) measurements on different sizes of pulmonary and liver lesions. The feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.

PET-CT images will be acquired on a Biograph Vision600 PET/CT, fitted with 26cm axial field of view and time of flight.

Phantom study will use an anthropomorphic TORSO phantom with a programmable motion phantom, mimicking respiratory motion (QUASAR). Spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. Concentration in the spheres will be the same for all diameters. The background and liver activities will be approximatively respectively 38 and 14 MBq. This phantom will be a simulating patient only for lung lesions.

The investigator will compare 6 different PET acquisitions: standard 3min acquisition without movement as our reference of "trues SUVmax and UV", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.

Patient study will be on 50 consecutive patients with lung or liver nodules. 18F-FDG injection will be around 2.5 MBq/kg.

The investigator will compare 5 different PET acquisitions: standard acquisition with free respiratory movement as our reference of "trues SUVmax and UV", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.

Study of Different Gating Techniques for PET Image of Lung and Liver Lesions

Study of Different Gating Techniques of Positron Emission Tomography Acquisition Focus on Lung or Liver Nodules. Comparaison on Phantoms and a Series of Patients

Classification, based on a phantom and patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for lung lesions

Classification, based on a patients studies, of the different gating system in view of the volume and SUV (max and peak) modification for liver lesions

Centre Hospitalier Princesse Grace

2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.

SonoVue

H. Wijkstra, Prof. Dr. Ir.

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.

The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.

Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Prostate cancer detection rate by quantification.

Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?

Prostate cancer Gleason score compared to quantification results

Answering the question: Is there a relation between Gleason score and quantification results?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PET Study With [89Zr]-Df-CriPec® Docetaxel	NCT03712423	Solid Tumor	Cripec Docetaxe...	18 Years -	Amsterdam UMC, location VUmc
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest
Study of Different Gating Techniques for PET Image of Lung and Liver Lesions	NCT05779865	Lung; Nodule Liver Metastase...		18 Years -	Centre Hospitalier Princesse Grace
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer	NCT01481441	Prostate Cancer	SonoVue	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest
Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma	NCT03382522	Prostate Cancer		18 Years -	University Hospital, Brest

Spots Global Cancer Trial Database for quantification