Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer

NCT03315351 | Completed

• 2 other identifiers: TEP-Curie-17022017-A01888-45
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Cancer

Keywords

PET-scan; Brachytherapy; Cervical Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition

  4 months

• Assessment of the HR-CTV coverage

  4 months

• Assessment of the dose received by the neighboring target organs

  4 months

• Time needed to design the different alternative treatment plans

  4 months

• Toxicity linked to the standard treatment driven by RMI only

  4 months

Study Arms (1)

Study Procedure

EXPERIMENTAL

Brachytherapy. PET-scan.

Procedure: Brachytherapy; Other: PET-scan

Interventions

Brachytherapy PROCEDURE

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

Study Procedure

PET-scan OTHER

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

Study Procedure

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy; Magnetic Resonance Spectroscopy

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)

Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Abel CORDOBA, MD

  Centre oscar Lambret de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 20, 2017
• Study Start: November 3, 2017
• Primary Completion: October 26, 2018
• Study Completion: March 11, 2019
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)