Evaluation of 68Ga-PSMA PET-CT in the initial extension assessment of advanced renal cell carcinoma a prospective, multicenter, open study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003760-47-FR

Enrollment

Registered

2019-10-04

Start date

2020-04-06

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

renal cell cancer (RCC)

Interventions

Product Name: 68Ga-PSMA Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years, • newly diagnosed patient for localized RCC intermediate or high risk (prognostic system UISS) or metastatic kidney cancer (M1 according to the TNM staging) with histological evidence (biopsy or surgical removal of part). • Recent conventional imaging review (from 1 month maximum on PET day at 68Ga-PSMA): - cerebral CT, chest and abdominopelvic CT with iodine injection comprising an arterial and portal and late time; - bone scintigraphy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

Exclusion criteria: • Pregnant or lactating woman; • History of other evolutionary neoplasia known in the previous 2 years

Design outcomes

Primary

Measure	Time frame
Main Objective: to prospectively evaluate the interest of 68Ga-PSMA PET-CT in the detection and characterization of metastatic lesions compared to baseline examinations (cerebral and thoracoabdominopelvic CT and bone scintigraphy) during the initial extension patients with clinically non-metastatic advanced renal cell cancer (RCC);Secondary Objective: - To evaluate the interest of 68Ga-PSMA PET-CT in the extension assessment in specific subgroups (subtypes and histological grades, ...). - To estimate the diagnostic performance of PET-CT at 68Ga-PSMA in the initial extension balance of advanced RCCs compared to the current standard balance. - To assess the impact of PET-CT 68Ga- PSMA in therapeutic intent and monitoring of patients with RCC. - To study the diagnostic performance of 68Ga-PSMA PET-CT on primary renal tumor when it is still in place.;Primary end point(s): The interest of PET-CT at 68Ga-PSMA will be defined by the number of patients for whom: • at least one lesion classified as 'malignant' in PET is not seen or classified as 'benign' by reference imaging, or • at least one lesion classified as 'malignant' by reference imaging is excluded (classified as 'benign') in PET.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: to prospectively evaluate the interest of 68Ga-PSMA PET-CT in the detection and characterization of metastatic lesions compared to baseline examinations (cerebral and thoracoabdominopelvic CT and bone scintigraphy) during the initial extension patients with clinically non-metastatic advanced renal cell cancer (RCC);Secondary Objective: - To evaluate the interest of 68Ga-PSMA PET-CT in the extension assessment in specific subgroups (subtypes and histological grades, ...). - To estimate the diagnostic performance of PET-CT at 68Ga-PSMA in the initial extension balance of advanced RCCs compared to the current standard balance. - To assess the impact of PET-CT 68Ga- PSMA in therapeutic intent and monitoring of patients with RCC. - To study the diagnostic performance of 68Ga-PSMA PET-CT on primary renal tumor when it is still in place.;Primary end point(s): The interest of PET-CT at 68Ga-PSMA will be defined by the number of patients for whom: • at least one lesion classified as 'malignant' in PET is not seen or classified as 'benign' by reference imaging, or • at least one lesion classified as 'malignant' by reference imaging is excluded (classified as 'benign') in PET.;Timepoint(s) of evaluation of this end point: 36 months

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Secondary

Measure	Time frame
Secondary end point(s): • The interest of 68Ga-PSMA PET-CT will be established according to the following factors: histological subtype, histological grade, TNM stage 2009, ECOG, biology, size of metastatic lesions, classification, anatomical location of metastatic lesions. • Diagnostic performance of 68Ga-PSMA PET-CT (sensitivity, specificity, negative and positive predictive values per patient and lesion) and comparison to the diagnostic performance of currently recommended reference examinations. • Comparison between the therapeutic intention (surgery, surveillance, radiotherapy, medical treatment ...) before the PET and the final therapeutic decision, description of the rate and the nature of the possible changes of care. • Qualitative visual analysis of the fixation and semi-quantitative analysis in 68Ga-PSMA PET-CT of the primary renal tumor if it is still in place.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Secondary end point(s): • The interest of 68Ga-PSMA PET-CT will be established according to the following factors: histological subtype, histological grade, TNM stage 2009, ECOG, biology, size of metastatic lesions, classification, anatomical location of metastatic lesions. • Diagnostic performance of 68Ga-PSMA PET-CT (sensitivity, specificity, negative and positive predictive values per patient and lesion) and comparison to the diagnostic performance of currently recommended reference examinations. • Comparison between the therapeutic intention (surgery, surveillance, radiotherapy, medical treatment ...) before the PET and the final therapeutic decision, description of the rate and the nature of the possible changes of care. • Qualitative visual analysis of the fixation and semi-quantitative analysis in 68Ga-PSMA PET-CT of the primary renal tumor if it is still in place.;Timepoint(s) of evaluation of this end point: 36 months

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Countries

France

Contacts

Public ContactDirection Recherche Santé

Assistance Publique Hôpitaux de Marseille

promotion.interne@ap-hm.fr00330491381705

Outcome results

None listed

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