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Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervix Carcinoma, Cervical Squamous Cell Carcinoma, Cervical Adenosquamous Carcinoma

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Trial Information

Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study


Inclusion Criteria:



- ≥ 18 years of age

- Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma,
or adenocarcinoma of the uterine cervix

- Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b

- Scheduled to undergo standard of care PET/CT for baseline assessment of disease

- Anticipated to be eligible for curative intent therapy (surgery of chemoradiation
therapy) as determined by the patient's primary oncologist

- If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats
prior to first PET/MRI

- Informed consent reviewed and signed

Exclusion Criteria:

- History of sever reaction to contrast-enhanced CT scan

- Inability to tolerate MRI (e.g., inability to lie flat > 1 hour)

- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear
implant or metal near eyes

- Poorly controlled diabetes mellitus

- Creatinine > 1.4 mg/dL or GFR < 30 mL/min

- Body Mass Index (BMI) > 35

- Active vaginal bleeding requiring packing and emergent radiation therapy

- Pregnant or lactating female

- History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years

- Substance abuse, medical, psychological, or social conditions that may interfere with
study participation

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Proportion of patients who successfully complete PET/MR scans at all study time-points

Outcome Time Frame:

2-3 months post-treatment

Safety Issue:

No

Principal Investigator

Julia Fielding, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

LCCC1221

NCT ID:

NCT01759355

Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

  • Cervix Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Cervical Adenosquamous Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous

Name

Location

University of North Carolina-Chapel HillChapel Hill, North Carolina  27599