Metastatic Solid TumorNCT05471271
IL-2 PET Imaging in Advanced Solid Tumours
A study testing [18F]AlF-RESCA-IL2 PET scan in people with Metastatic Solid Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer [18F]AlF-RESCA-IL2 in patients prior to and during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor
- What is being tested?
- [18F]AlF-RESCA-IL2 PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2023to 1 Nov 2024
- 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 at the time of signing informed consent.
- Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care.
- At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
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- Signed informed consent.
- Willingness and ability to comply with all protocol required procedures.
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (< 1% per year) when used consistently and correctly)).
Who cannot join
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [18F]AlF-RESCA-IL2 injection.
- Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to [18F]AlF-RESCA-IL2 injection.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of [18F]AlF-RESCA-IL2, or that may affect the interpretation of the results or render the patient at high risk from complications.
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Sponsor employee/member of the clinical site study team and/or his or her immediate family
- Pregnant or lactating females.
- Concurrent use of systemic corticosteroids > 10 mg daily prednisone equivalent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Pilot Study of [18AlF]-RESCA-IL2 (Interleukin-2 PET Tracer) for Positron Emission Tomography Imaging in Patients Treated With Immune Checkpoint Inhibitors.
This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer [18F]AlF-RESCA-IL2 in patients prior to and during treatment.
- Conditions
- Metastatic Solid Tumor
- Being tested
- [18F]AlF-RESCA-IL2 PET scan
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AlF-RESCA-IL2 PET scanOther
Patients will undergo [18F]AlF-RESCA-IL2 PET imaging twice; the first [18F]AlF-RESCA-IL2 PET scan will be performed at baseline, before starting therapy. The second [18F]AlF-RESCA-IL2 PET scan will be performed after 2 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| [18AlF]-RESCA-IL2 PET imaging | Other | Not described Receives: Other: [18F]AlF-RESCA-IL2 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0
Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated) and changes in vital signs. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0
Measured: 2 years
Non-displaceable binding potential (BPND)
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Measured: 2 years
Total volume of distribution (VT) of the tracer in the tumour
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Measured: 2 years
Biodistribution of [18F]-AlF-RESCA-IL2
Evaluation of [18F]AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in tumours, healthy tissues and organs.
Measured: 2 years
Secondary outcomes (3)
Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.
Results of immunohistochemical (IHC) scoring of immune cell IL-2R expression will be described as a semi-quantitative score using the percentage of positive cells (continuous variable), intensity and pattern of staining (discrete variable). These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Measured: 2 years
Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
Response to therapy will be assessed according to the RECIST or iRECIST guidelines. These results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Measured: 2 years
Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.
Patients will undergo a PET scan at baseline and another one during treatment. tracer uptake will be quantified and expressed as standardized uptake value (SUV) in defined volumes of interest (VOIs) for both scans. The results of both PET scans will be compared to assess changes in imaging tracer uptake over time.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start2 Oct 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: Instability of the IL2 tracer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471271
- Sponsor's protocol ID
- 202100912
- Status last verified
- May 2025
- First submitted
- 29 Jun 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of [18AlF]-RESCA-IL2 (Interleukin-2 PET Tracer) for Positron Emission Tomography Imaging in Patients Treated With Immune Checkpoint Inhibitors.
- ClinicalTrials.gov ID
- NCT05471271
- Acronym / sponsor ID
- 202100912
- Conditions
- Metastatic Solid Tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Instability of the IL2 tracer
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 22 Jul 2022 (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.
This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer [18F]AlF-RESCA-IL2 in patients prior to and during treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18AlF]-RESCA-IL2 PET imaging | Other | Other: [18F]AlF-RESCA-IL2 PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years at the time of signing informed consent.
- Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care.
- At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
- Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (7 listed)
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to [18F]AlF-RESCA-IL2 injection.
- Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to [18F]AlF-RESCA-IL2 injection.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of [18F]AlF-RESCA-IL2, or that may affect the interpretation of the results or render the patient at high risk from complications.
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Sponsor employee/member of the clinical site study team and/or his or her immediate family
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 |
|---|---|---|
| [18F]AlF-RESCA-IL2 PET scanPatients will undergo [18F]AlF-RESCA-IL2 PET imaging twice; the first [18F]AlF-RESCA-IL2 PET scan will be performed at baseline, before starting therapy. The second [18F]AlF-RESCA-IL2 PET scan will be performed after 2 weeks of treatment | Other | [18AlF]-RESCA-IL2 PET imaging |
Primary outcome
Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0
Time frame: 2 years
Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated) and changes in vital signs. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0
Non-displaceable binding potential (BPND)
Time frame: 2 years
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Total volume of distribution (VT) of the tracer in the tumour
Time frame: 2 years
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Biodistribution of [18F]-AlF-RESCA-IL2
Time frame: 2 years
Evaluation of [18F]AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in tumours, healthy tissues and organs.
3 secondary outcomes
Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.
Time frame: 2 years
Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
Time frame: 2 years
Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Instability of the IL2 tracer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]AlF-RESCA-IL2 PET scan in people with Metastatic Solid Tumor, run by University Medical Center Groningen at 1 site in Netherlands.
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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Instability of the IL2 tracer). Results are not available in the source record.
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?
Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0 (time frame: 2 years). The study lists 4 primary outcomes in all. 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 31 May 2025.