Investigation of 68GaPSMA PET/CT as an imaging biomarker in solid tumors

Investigation of 68GaPSMA PET/CT as an imaging biomarker in solid tumors - BASKET GA-PSMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004376-21-IT

Enrollment

400

Registered

2018-09-20

Start date

2017-05-17

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

advanced/metastatic solid tumors MedDRA version: 20.0 Level: LLT Classification code 10027477 Term: Metastatic carcinoma System Organ Class: 100000004864

Interventions

Product Name: 68Ga-HBED-CC-PSMA_IRSTIRCCS Product Code: 68Ga-HBED-CC-PSMA_IRSTIRCCS Pharmaceutical Form: Solution for infusion INN or Proposed INN: 68Ga-HBED-CC-PSMA_IRSTIRCCS Current Sponsor code: 68

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with mCRPC or advanced/metastatic solid tumors; 2. Relapse or progression disease on CT scan and / or MR; 3. Age = 18 years; 4. Written informed consent 5. ECOG performance status =2 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220

Exclusion criteria

Exclusion criteria: 1. Pregnancy / Nursing; 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study. 3. inability to remain still for the entire duration of the exam

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the detection rate of 68Ga-PSMA PET/CT, defined as the ratio of 68Ga-PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a 68Ga-PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one 68Ga-PSMA-positive lesion.;Secondary Objective: Safety; Lesions detection rate stratified per tumour histotypes; Lesions detection rate stratified for different lesion sites; To evaluate patients’eligibility for 177Lu-PSMA therapy; To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy; Reduce kidney uptake with diuretic treatment. ;Primary end point(s): detection rate of the 68Ga-PSMA PET/CT in mCRPC or advanced/metastatic cancer patients, defined as the proportion of 68Ga-PSMA- positive patients and the total number of recruited patient;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the detection rate of 68Ga-PSMA PET/CT, defined as the ratio of 68Ga-PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a 68Ga-PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one 68Ga-PSMA-positive lesion.;Secondary Objective: Safety; Lesions detection rate stratified per tumour histotypes; Lesions detection rate stratified for different lesion sites; To evaluate patients’eligibility for 177Lu-PSMA therapy; To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy; Reduce kidney uptake with diuretic treatment. ;Primary end point(s): detection rate of the 68Ga-PSMA PET/CT in mCRPC or advanced/metastatic cancer patients, defined as the proportion of 68Ga-PSMA- positive patients and the total number of recruited patient;Timepoint(s) of evaluation of this end point: 36 months

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Secondary

Measure	Time frame
Secondary end point(s): 1) Safety 2) Lesions detection rate stratified per tumour histotypes 3) Lesions detection rate stratified for different lesion sites 4) To evaluate patients’ eligibility for 177Lu-PSMA therapy 5) To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy 6) Reduce kidney uptake with diuretic treatment;Timepoint(s) of evaluation of this end point: 1) 36 months 2) 36 months 3) 36 months 4) 36 months 5) 36 months 6) 36 months	—

Measure

Time frame

Secondary end point(s): 1) Safety 2) Lesions detection rate stratified per tumour histotypes 3) Lesions detection rate stratified for different lesion sites 4) To evaluate patients’ eligibility for 177Lu-PSMA therapy 5) To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy 6) Reduce kidney uptake with diuretic treatment;Timepoint(s) of evaluation of this end point: 1) 36 months 2) 36 months 3) 36 months 4) 36 months 5) 36 months 6) 36 months

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Countries

Italy

Contacts

Public ContactCentro di Coordinamento Studi IRST

IRST IRCCS

cc.ubsc@irst.emr.it0544285813

Outcome results

None listed

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