Impact of Body Composition on Dosimetry of 177Lu-PSMA Radioligand Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCentre Henri Becquerel
About this trial
COCORIVO is an interventional study evaluating the impact of body composition on dosimetry of 177Lu-PSMA radioligand therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Body composition (muscle, lean, visceral fat, subcutaneous fat and total fat masses) will be automatically quantified from whole-body CT images acquired at 72-96h after 177Lu-PSMA injection using the Anthropometer3DNet software. Dosimetry will be evaluated for tumors and organs at risk (salivary glands, bone marrow, kidneys). The study also evaluates the impact of body composition on SUV quantification, the feasibility of single-timepoint dosimetry, and the evolution of body composition during treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Male, age >= 18 years
Histologically confirmed prostatic adenocarcinoma with multidisciplinary decision for 177Lu-PSMA treatment
PSMA expression in tumor lesions confirmed by 68Ga-PSMA PET/CT
Disqualifiers
Patient unable to understand the study or comply with study constraints (language barrier, psychological, geographic...)
Patient under legal protection (tutelle, curatelle, sauvegarde de justice)
Trial design
Design model
Single group
Treatments tested in this trial
177Lu-PSMA-617 + SPECT/CT dosimetry
Radiation177Lu-PSMA-617 7400 MBq IV, 4 to 6 cycles every 6 weeks (standard of care). Additional interventions: whole-body SPECT/CT at 4-24H and/or 168-196H post-injection (research acquisitions) for dosimetry. Body composition analysis from SPECT/CT scanner using Anthropometer3DNet. MNA questionnaire and nutritional blood tests at baseline and end of treatment.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: COCORIVOExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tumor and organ-at-risk dosimetry as a function of body composition
Dosimetry (Gy) of all tumors and organs at risk (salivary glands, bone marrow, kidneys) evaluated by SPECT/CT at 72-96H post-injection. Patients classified into two categories based on median body composition of the study population.
Time frame
After cycle 1 of 177Lu-PSMA treatment (approximately week 1)Secondary outcomes
1
Comparison of SUV vs SUL in 68Ga-PSMA PET/CT and 177Lu-PSMA SPECT/CT
Comparison of SUV (normalized by total body mass) and SUL (normalized by lean body mass) of lesions and organs at risk. Difference \<20% considered equivalent.
Time frame
Baseline and after cycle 1 (approximately week 1)2
Evaluate the differences between a single-point dosimetric approach based on population pharmacokinetics and a multi-point approach
Comparison of dosimetry
Time frame
196 hours after the injection of the first cycle of 177LuPSMASponsors and contacts
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Source ClinicalTrials.gov
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