Kidney CancerIBM-RenalNCT06016075
Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
A study testing Hyperpolarised MRI, Sodium MRI and Deuterium metabolic imaging (DMI) MRI in people with Kidney Cancer, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Hyperpolarised MRI, Sodium MRI and Deuterium metabolic imaging (DMI) MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years old
- Able to and provide written informed consent to participate
- If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception
- If male, using a suitable contraceptive method for the duration of the study
- Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice
- Capable of undergoing a minimum of one study visit
Who cannot join
- Contraindication or inability to tolerate MRI
- Pregnant or actively breast-feeding woman
- If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)
- Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
- Laboratory abnormalities that may impact on the study results
- Any other significant medical or psychiatric history rendering the subject ineligible as deemed by the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Department of Radiology
Cambridge, Cambridgeshire, CB2 0QQ
Ines Horvat-Menih, MD, +44 1223 767062, ih357@cam.ac.uk
About this study
The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.
- Conditions
- Kidney Cancer
- Being tested
- Hyperpolarised MRI, Sodium MRI, Deuterium metabolic imaging (DMI) MRI
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarised MRIDevice
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Sodium MRIDevice
MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
Deuterium metabolic imaging (DMI) MRIDevice
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarised MRI | Other | Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans. Receives: Device: Hyperpolarised MRI |
| Sodium MRI | Other | MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium. Receives: Device: Sodium MRI |
| Deuterium metabolic imaging (DMI) MRI | Other | Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans. Receives: Device: Deuterium metabolic imaging (DMI) MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAC/PYR ratio
LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.
Measured: 1 year
Total Sodium Concentration
Total Sodium Concentration - in renal tumours
Measured: 1 year
Technical development of DMI in the abdomen
Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jan 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Horvat-Menih, University of Cambridge
- Investigators
- Ferdia A Gallagher, MD PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016075
- Sponsor's protocol ID
- Radiology, Uni of Cambridge
- Other IDs
- 22/EE/0136, 314155
- Acronym
- IBM-Renal
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Horvat-Menih I, McLean MA, Zamora-Morales MJ, Wylot M, Kaggie J, Khan AS, Gill AB, Duarte J, Locke MJ, Mendichovszky I, Li H, Priest AN, Warren AY, Welsh SJ, Jones JO, Armitage JN, Mitchell TJ, Stewart GD, Gallagher FA. Multiarm, non-randomised, single-centre feasibility study-investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal): protocol. BMJ Open. 2024 Oct 26;14(10):e083980. doi: 10.1136/bmjopen-2024-083980.
PubMed 39461869
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
- ClinicalTrials.gov ID
- NCT06016075
- Acronym / sponsor ID
- IBM-Renal / Radiology, Uni of Cambridge
- Conditions
- Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 29 Aug 2023 (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.
The aim of this study is to develop techniques for non-invasive imaging of biology in participants with benign or malignant renal masses based on the novel scanning MRI techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of 13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or 3) acquire imaging data from human tissues following the oral consumable of deuterated glucose. Data acquired during this physiological study will be used to optimise future imaging protocols.In the UK and possibly in other countries, there are some patients with renal masses that are over treated or undergo unnecessary procedures such as surgery or biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but after the procedure it is found that the mass was benign. The aim of this study is to determine whether one or all of these imaging techniques can differentiate between benign and malignant renal masses with the view to developing the techniques further and hopefully reducing the need for over treatment or unnecessary procedures in patients with benign masses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarised MRI | Other | Device: Hyperpolarised MRIHyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans. |
| Sodium MRI | Other | Device: Sodium MRIMRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium. |
| Deuterium metabolic imaging (DMI) MRI | Other | Device: Deuterium metabolic imaging (DMI) MRIDrink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old
- Able to and provide written informed consent to participate
- If female, postmenopausal or if women of child bearing potential (WOCBP) using a suitable contraception
- If male, using a suitable contraceptive method for the duration of the study
- Radiologically suspected or pathologically confirmed benign or malignant renal masses, as determined by standard clinical practice
Key exclusion criteria (6 listed)
- Contraindication or inability to tolerate MRI
- Pregnant or actively breast-feeding woman
- If using an intrauterine contraceptive device (IUCD) as a method of contraception the device should be MRI safe at 3 T (researcher to confirm)
- Clinically significant cardiac, pulmonary or neurological diseases as determined by the investigators
- Laboratory abnormalities that may impact on the study results
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 |
|---|---|---|
| Hyperpolarised MRIHyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans. | Device | Hyperpolarised MRI |
| Sodium MRIMRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium. | Device | Sodium MRI |
| Deuterium metabolic imaging (DMI) MRIDrink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans. | Device | Deuterium metabolic imaging (DMI) MRI |
Primary outcome
LAC/PYR ratio
Time frame: 1 year
LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.
Total Sodium Concentration
Time frame: 1 year
Total Sodium Concentration - in renal tumours
Technical development of DMI in the abdomen
Time frame: 1 year
Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 39461869Horvat-Menih I, McLean MA, Zamora-Morales MJ, Wylot M, Kaggie J, Khan AS, Gill AB, Duarte J, Locke MJ, Mendichovszky I, Li H, Priest AN, Warren AY, Welsh SJ, Jones JO, Armitage JN, Mitchell TJ, Stewart GD, Gallagher FA. Multiarm, non-randomised, single-centre feasibility study-investigation of the differential biology between benign and malignant renal masses using advanced magnetic resonance imaging techniques (IBM-Renal): protocol. BMJ Open. 2024 Oct 26;14(10):e083980. doi: 10.1136/bmjopen-2024-083980.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Ferdia A Gallagher, MD PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperpolarised MRI, Sodium MRI and Deuterium metabolic imaging (DMI) MRI in people with Kidney Cancer, run by University of Cambridge at 1 site in United Kingdom.
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 6 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Horvat-Menih, MD (+44 1223 767062, ih357@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAC/PYR ratio (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016075, which also lists 1 linked publication.
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 5 Dec 2024.