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Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques (IBM-Renal)

Primary Purpose

Kidney Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hyperpolarised MRI
Sodium MRI
Deuterium metabolic imaging (DMI) MRI
Sponsored by
University of Cambridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University Department of RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Hyperpolarised MRI

Sodium MRI

Deuterium metabolic imaging (DMI) MRI

Arm Description

Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.

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.

Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.

Outcomes

Primary Outcome Measures

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.
Total Sodium Concentration
Total Sodium Concentration - in renal tumours
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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
October 24, 2023
Sponsor
University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT06016075
Brief Title
Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Acronym
IBM-Renal
Official Title
Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cambridge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperpolarised MRI
Arm Type
Other
Arm Description
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Arm Title
Sodium MRI
Arm Type
Other
Arm Description
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.
Arm Title
Deuterium metabolic imaging (DMI) MRI
Arm Type
Other
Arm Description
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Intervention Type
Device
Intervention Name(s)
Hyperpolarised MRI
Intervention Description
Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
Intervention Type
Device
Intervention Name(s)
Sodium MRI
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Deuterium metabolic imaging (DMI) MRI
Intervention Description
Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
Primary Outcome Measure Information:
Title
LAC/PYR ratio
Description
LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.
Time Frame
1 year
Title
Total Sodium Concentration
Description
Total Sodium Concentration - in renal tumours
Time Frame
1 year
Title
Technical development of DMI in the abdomen
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ines Horvat-Menih, MD
Phone
+44 1223 767062
Email
ih357@cam.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Wylot, PhD
Phone
+44 1223 767062
Email
mw699@medschl.cam.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferdia A Gallagher, MD PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Department of Radiology
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Horvat-Menih, MD
Phone
+44 1223 767062
Email
ih357@cam.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques

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