Molecular Imaging and Spectroscopy With Stable Isotopes in Oncology and Neurology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with known ovarian cancer will be imaged up to four times with FDG-PET, C13 MRI and other novel MRI techniques during their treatment course including: before the start of any treatment (with optional repeat scanning), after the first dose of chemotherapy (optional), after the third dose of chemotherapy (optional) and after surgery (optional). Imaging findings will be compared to biological properties of cancer tissue samples.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diffusion-weighted Imaging Study in Cancer of the Ovary

NCT01505829

Ovarian Cancer Peritoneal Metastases

COMPLETED

Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

NCT02792959

Ovarian Cancer

COMPLETED NA

Evaluation of OE-MRI in Patients With H&N Cancer

NCT04724096

Head and Neck Squamous Cell Carcinoma

COMPLETED

Hyperpolarised 13C-Pyruvate MRI Study

NCT03687645

Cancer Cardiovascular Diseases

UNKNOWN NA

Simultaneous Hyperpolarized [1-13C]Pyruvate and 18F-FDG PET/MRS in Cancer Patients

NCT05396118

Breast Cancer Neuroendocrine Tumors Neuroendocrine Carcinoma +3 more

ENROLLING_BY_INVITATION PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-centre prospective physiological study.

1. Participants will be recruited through MDTs and clinics.
2. Baseline screening blood tests will be performed.
3. Baseline MRI will be undertaken to identify lesions to be studied. This will be followed by hyperpolarised carbon-13 MRSI after the injection of hyperpolarised 13C-pyruvate. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.
4. A subset of patients (up to 10) will undergo repeat hyperpolarised carbon-13 MRSI within 5 days of baseline imaging to assess for reproducibility of the imaging test.
5. Where possible, image-guided biopsy will be performed to obtain tissue from selected lesions for analysis.
6. During the first month of and later during systemic anticancer therapy, MRI and carbon-13 MRSI will be again carried out to assess to look for changes in pyruvate metabolism. If possible, a further biopsy will be undertaken at this stage. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.
7. MRI and carbon-13 MRSI will be carried out after the full course of systemic anticancer therapy, to assess for treatment response and to identify lesions in preparation for tissue extraction at surgery. Scanning with 18F-FDG PET in combination with CT or MRI may optionally be performed in the same imaging visit.
8. During surgery, tissue samples will be collected either by excision or biopsy.
9. MRI may be performed after surgery in selected patients.
10. In up to 10 participants, carbon-13 MRSI will be done 3 to 6 weeks after surgery to look for areas of pyruvate or lactate accumulation that may correlate with long term prognosis. Only participants who are not part of the subset undergoing retest carbon-13 MRSI to assess for reproducibility will be invited for post-surgical carbon-13 MRSI, this is to keep the number of carbon-13 MRSI scans each participant has at a maximum of four in order to minimise inconvenience to participants caused by having to make repeat visits for imaging.
11. Participants will be followed up for one year in the clinic and/or through their GP.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ovarian cancer patients

MRI and FDG-PET imaging

MRI scan and FDG-PET scan

Intervention Type DIAGNOSTIC_TEST

Scanning with MRI and FDG-PET

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI scan and FDG-PET scan

Scanning with MRI and FDG-PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* To be included in this study the patient must:

1. Be 18 years or older.
2. Have a confirmed or likely diagnosis of HGSOC, breast cancer, prostate cancer, pancreatic mass, liver mass, renal mass or brain tumour.
3. Be aware of their diagnosis.
4. Be a likely surgical candidate who is fit for possible surgery.
5. Have no contraindications to the use of the IV contrast agents involved in this study.
6. Be able to provide written informed consent according to ICH/GCP, national and local regulations.
7. Volunteers of childbearing potential must have a negative pregnancy test, either urinary or blood prior to enrolment.
8. Have ECOG performance status 0 or 1.
9. Express willingness and ability to comply with scheduled visits, laboratory tests, imaging and other study procedures.

Exclusion Criteria

* The presence of any of the following will preclude the patient from the study:

1. Any disorder that may adversely affect levels of pyruvate or lactate such as diabetes mellitus.
2. The use of medications that may affect levels of pyruvate or lactate such as metformin or insulin.
3. Known allergy or adverse reaction to any of the injected contrast agents proposed for use in this study.
4. Pregnancy or breastfeeding.
5. Other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or in the judgement of the investigators make it undesirable for the patient to enter the study.
6. Laboratory abnormalities that may have an unknown or unpredictable impact on study results.
7. Not suitable for MR scanning e.g. severe obesity, inability to lie still or contraindicated metal implants such as the intrauterine contraceptive device.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No