Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer (TEP-Curie)

Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy

Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: Brachytherapy; Other: PET-scan

Detailed Description

The study will proceed as follow:

• Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy).
• additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy)
• 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59020
    • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient suffering from a cervical cancer:
• squamous-cell carcinoma or adenocarcinoma histologically proven
• classified from FIGO 2009 IB2 to IVA stage
• Age ≥ 18 years old
• Examination by PET-scan and pelvic RMI realized at diagnosis
• Examination by negative PET-scan remotely closed and at lymph node level
• Surgical lymphadenectomy negative at paraaortic level
• Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done
• Scheduled curative treatment by brachytherapy driven by RMI
• Affiliation to the National Social Security System
• With informed and signed consent before any procedure specific to the study

Exclusion Criteria:

• Performance status of WHO score > 2
• Other histology than squamous cell carcinoma or adenocarcinoma
• Metastatic patient or paraaortic node positive
• Adjuvant radiochemotherapy after the first surgery
• Dementia or psychiatric history
• Kidney failure
• Diabet
• Chronic inflammatory bowel disease
• Pelvic and/or vesicoureteral surgery history
• Pelvic irradiation history
• Other active neoplasia or < 5 years old, except for basocellular carcinoma that can be locally treated
• Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia
• Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.
• Treatment with palliative intent
• Pregnant or breastfeeding women
• Patient Under guardianship or tutorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Procedure; Brachytherapy. PET-scan.

Procedure: Brachytherapy; Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized. The brachytherapy include a pulsating flow treatment driven by RMI and CT-scan; Other: PET-scan; The patient will undergo 2 PET-scan during the clinical trial: the first one is additional to the brachytherapy; the second one is realized 4 months after the brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams	Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam	4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)	Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET	4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer	Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format	4 months
Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility	Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition	Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone	4 months
Assessment of the HR-CTV coverage	Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone	4 months
Assessment of the dose received by the neighboring target organs	Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone	4 months
Time needed to design the different alternative treatment plans		4 months
Toxicity linked to the standard treatment driven by RMI only	Graded according to the NCI CTCAE v4. scale	4 months

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Investigators: Principal Investigator: Abel CORDOBA, MD, Centre oscar Lambret de Lille

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): October 26, 2018
• Study Completion (Actual): March 11, 2019

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cervical Cancer; Brachytherapy; PET-scan
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Investigative Techniques; Therapeutics; Chemistry Techniques, Analytical; Spectrum Analysis; Radiotherapy; Magnetic Resonance Spectroscopy; Brachytherapy
• Other Study ID Numbers: TEP-Curie-1702; 2017-A01888-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No