Kidney CancersREIN-TEP PSMANCT07624578
Evaluation of 68Ga-PSMA PET-CT in the Initial Staging of Advanced Renal Cell Carcinomas - A Prospective, Multicentre, Open-label Study
A study testing 68Ga-PSMA PET-CT scan in people with Kidney Cancers, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Kidney cancer in adults is the seventh leading cause of cancer-related death in France. Early and accurate imaging of the primary tumour and the identification of metastatic sites are major prognostic factors that are crucial for determining the appropriate stage-specific treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancers
- What is being tested?
- 68Ga-PSMA PET-CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, enrolled in a social security scheme.
- Signed informed consent form.
- Patient newly diagnosed with localised intermediate- or high-risk renal cell carcinoma (UISS prognostic system) or metastatic renal cancer (M1 according to TNM staging) with histological evidence (biopsy or surgical specimen).
- Recent conventional imaging work-up (dated no more than 1 month prior to the 68Ga-PSMA PET scan):
- Brain CT, chest and abdominal-pelvic CT with iodine injection, including arterial, portal and late phases;
- Bone scan (BS);
Who cannot join
- Pregnant or breastfeeding women;
- History of another known progressive neoplasm within the past two years
About this study
Kidney cancer in adults is the seventh leading cause of cancer-related death in France. Early and accurate imaging of the primary tumour and the identification of metastatic sites are major prognostic factors that are crucial for determining the appropriate stage-specific treatment. However, the diagnosis of sub-centimetre metastatic lymph nodes and occult metastatic lesions remains difficult with current imaging methods. Recent publications have shown promising results for 68Ga-PSMA PET-CT in the detection of metastases from renal cell carcinoma (RCC). It is therefore necessary to develop a new, more sensitive and specific imaging method to detect occult metastatic foci, enabling the earlier initiation of specific systemic or local treatment, and thereby improving survival in these patients or even achieving prolonged remission in oligometastatic cases Experience and acceptability of a new organisational model in primary care: participatory multi-professional health centres
- Conditions
- Kidney Cancers
- Being tested
- 68Ga-PSMA PET-CT scan
- Keywords
- Kidney cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA PET-CT scanDiagnostic test
A 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations
| Study group | Role | What they receive |
|---|---|---|
| TEP-TDM au 68Ga-PSMA | Experimental | A 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations Receives: Diagnostic Test: 68Ga-PSMA PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
classification of the lesion as 'malignant' or 'benign'
The value of 68Ga-PSMA PET-CT will be determined by the number of patients for whom:
- at least one lesion classified as 'malignant' on PET is not visible or is classified as 'benign' on the reference imaging, or
- at least one lesion classified as 'malignant' by the reference imaging is ruled out (classified as 'benign') on PET.
The 'malignant'/'benign' classification of the lesion is based on 68Ga-PSMA PET-CT and on the reference imaging,
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJan 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Due to administrative issues, the study was abandoned before recruitment began.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624578
- Sponsor's protocol ID
- 2019-003760-47
- Other IDs
- 2019-003760-47, 2019
- Acronym
- REIN-TEP PSMA
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study withdrawned
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 68Ga-PSMA PET-CT in the Initial Staging of Advanced Renal Cell Carcinomas - A Prospective, Multicentre, Open-label Study
- ClinicalTrials.gov ID
- NCT07624578
- Acronym / sponsor ID
- REIN-TEP PSMA / 2019-003760-47
- Conditions
- Kidney Cancers
- Keywords
- Kidney cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to administrative issues, the study was abandoned before recruitment began.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney cancer in adults is the seventh leading cause of cancer-related death in France. Early and accurate imaging of the primary tumour and the identification of metastatic sites are major prognostic factors that are crucial for determining the appropriate stage-specific treatment. However, the diagnosis of sub-centimetre metastatic lymph nodes and occult metastatic lesions remains difficult with current imaging methods. Recent publications have shown promising results for 68Ga-PSMA PET-CT in the detection of metastases from renal cell carcinoma (RCC). It is therefore necessary to develop a new, more sensitive and specific imaging method to detect occult metastatic foci, enabling the earlier initiation of specific systemic or local treatment, and thereby improving survival in these patients or even achieving prolonged remission in oligometastatic cases Experience and acceptability of a new organisational model in primary care: participatory multi-professional health centres
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEP-TDM au 68Ga-PSMA | Experimental | Diagnostic Test: 68Ga-PSMA PET-CT scanA 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, enrolled in a social security scheme.
- Signed informed consent form.
- Patient newly diagnosed with localised intermediate- or high-risk renal cell carcinoma (UISS prognostic system) or metastatic renal cancer (M1 according to TNM staging) with histological evidence (biopsy or surgical specimen).
- Recent conventional imaging work-up (dated no more than 1 month prior to the 68Ga-PSMA PET scan):
- Brain CT, chest and abdominal-pelvic CT with iodine injection, including arterial, portal and late phases;
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women;
- History of another known progressive neoplasm within the past two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-PSMA PET-CT scanA 68Ga-PSMA PET-CT scan will be performed on all patients newly diagnosed with advanced, clinically non-metastatic CRC who have passed the baseline examinations | Diagnostic test | TEP-TDM au 68Ga-PSMA |
Primary outcome
classification of the lesion as 'malignant' or 'benign'
Time frame: 1 month
The value of 68Ga-PSMA PET-CT will be determined by the number of patients for whom: * at least one lesion classified as 'malignant' on PET is not visible or is classified as 'benign' on the reference imaging, or * at least one lesion classified as 'malignant' by the reference imaging is ruled out (classified as 'benign') on PET. The 'malignant'/'benign' classification of the lesion is based on 68Ga-PSMA PET-CT and on the reference imaging,
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. study withdrawned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-PSMA PET-CT scan in people with Kidney Cancers, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
classification of the lesion as 'malignant' or 'benign' (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.