Hyperpolarized 13C MR Imaging of Lactate in Patients With Locally Advanced Cervical Cancer (LACC) Cervical Cancer

NCT03129776 | Terminated Phase 1 FDA Drug

• 1 other identifier: 355-2016
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to image tumour lactate in study participants with locally advanced cervical cancer. Our hypothesis is that lactate content in cervical tumours, as measured by hyperpolarized 13C Magnetic Resonance (MR) imaging, will correlate with diffusion-weighted MRI and 18FDG-PET (fluorodeoxyglucose-positron emission tomography). Furthermore, lactate imaging will potentially provide additional and more specific information regarding the metabolic activity of cervical tumours, thereby identifying regions of radiation resistance and guiding radiation treatment and brachytherapy.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Time resolved, 3D 13C lactate images from subjects with cervical cancer.

  Feasibility of acquiring time resolved, 3D 13C lactate images from subjects with cervical cancer.

  1 year

Secondary Outcomes (1)

• Correlation of MRI and 18FDG-PET images

  1 Year

Study Arms (2)

Hyperpolarized Pyruvate (13C) Injection

ACTIVE COMPARATOR

Participants will be injected with the study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43 ml/kg and will have their cervix imaged using MRI.

Drug: Hyperpolarized 13C-Pyruvate

18F-FDG

ACTIVE COMPARATOR

Participants will be injected with the study drug 18F-FDG at a dose of 5 MBq/kg to a a maximum of 500 MBq (megabecquerel) and will have their cervix imaged using PET-CT imaging.

Drug: 18F-FDG

Interventions

Hyperpolarized 13C-Pyruvate DRUG

The new imaging method being tested is called Metabolic MRI, which provides pictures of the metabolism occurring within cancer cells. It also involves injection of a contrast agent, Hyperpolarized Pyruvate (13C) Injection, into the arm vein. The participants will be injected with the study drug at a dose of 0.43 ml/kg and then receive a MRI scan.

Hyperpolarized Pyruvate (13C) Injection

18F-FDG DRUG

18F-FDG is a radiopharmaceutical used in medical imaging. The uptake of 18F-FDG by tissues is a marker for the tissue uptake of glucose, which is correlated with certain types of tissue metabolism, particularly in cancer cells. The participant will be injected with the study drug at a dose of 5 MBq/kg to a maximum of 500 MBq and then receive a PET scan.

18F-FDG

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biological females with a cervix will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, International Federation of Gynecology and Obstetrics (FIGO) stage IB-IVA
• Planned treatment with radical radiotherapy with or without concurrent cisplatin chemotherapy.
• Age ≥ 18 years.

You may not qualify if:

• Any anticancer treatment for their cervical cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status \> 2
• Other cervical cancer tumor histologies (e.g. small cell, serous)
• Contraindications to 18FDG PET-CT
• Inability to lie supine for 18FDG PET-CT
• Contraindication to radiotherapy (e.g. severe Crohn's disease)
• History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years.
• Known pregnancy or lactating

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Up to ten participants with newly diagnosed FIGO stage IB-IVA cervical cancer that are to receive definitive radiation with or without concurrent cisplatin, are to be recruited for this prospective single institutional study. Participants will receive a hyperpolarized carbon 13 MR spectroscopy and PET scan in addition to the standard imaging that is required for staging. A tumour biopsy will be obtained at the time of the initial clinic visit.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 26, 2017
• Study Start: November 13, 2017
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)