Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention (APACH2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04040946
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : June 22, 2020
Sponsor:
Collaborator:
Fondation de l'Avenir
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:
The investigators hypothesize that positron emission tomography with fluorocholline (F18-choline PET) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus MIBI scintigraphy (Tc99m-sestaMIBI ) will be offset by lower cost in terms of type. surgery performed wisely and complications.

Condition or disease Intervention/treatment Phase
Parathyroid Adenoma Hyperparathyroidism F18-choline Diagnostic Test: MIBI scintigraphy Diagnostic Test: F18-choline PET Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open, randomized, phase III study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase III Trial Comparing 2 Diagnostic Strategies for Preoperative Localization of Parathyroid Adenoma in Primary Hyperparathyroidism:TEMP / CT With Tc99m-sestaMIBI or PET / CT With F18-choline in First Intention
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
TEMP-TDM with MIBI
Performing a MIBI scintigraphy, then, in the case of negativity, a F18-choline PET
Diagnostic Test: MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
Other Name: F18-choline PET

Diagnostic Test: F18-choline PET
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Other Name: MIBI scintigraphy

F18-choline PET
Realization of F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Diagnostic Test: MIBI scintigraphy
Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
Other Name: F18-choline PET

Diagnostic Test: F18-choline PET
Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
Other Name: MIBI scintigraphy




Primary Outcome Measures :
  1. Compare, between each diagnostic strategy, the proportion of patients for whom the first-line imaging technique guided the surgical procedure wisely [ Time Frame: Up to 2 months ]

Secondary Outcome Measures :
  1. Estimate the diagnostic performance of each strategy by measuring sensitivity and specificity [ Time Frame: Up to 2 months ]
  2. Evaluate post-surgical complications by measuring tne number of infections, hematoma [ Time Frame: Up to 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient 18 years old
  • Patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned
  • For women of childbearing age, negative pregnancy test at Baseline
  • Biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum PTH and calcium concentrations)
  • Affiliation to a social security scheme
  • Patient having signed his written consent

Exclusion Criteria:

  • Patient deprived of liberty, under tutorship or curatorship
  • Hypersensitivity to TECNESCAN SESTAMIBI
  • Any associated medical or psychological condition that could compromise the patient's ability to participate in the study
  • Pregnant or lactating woman
  • History of parathyroid surgery
  • Patient with multiple endocrine neoplasia 1 (NEM1)
  • Known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040946


Contacts
Layout table for location contacts
Contact: QUAK Elske, MD +33 2 31 45 50 02 e.quak@baclesse.unicancer.fr
Contact: GRELLARD Jean-Michel, Project manager +33 (0)2 31 45 50 02 jm.grellard@baclesse.unicancer.fr

Locations
Layout table for location information
France
CHU Brest Not yet recruiting
Brest, France
Contact: Marie-Béatrice CAVAREC-PEGULLO, MD         
Principal Investigator: Marie-Béatrice CAVAREC-PEGULLO, MD         
Sub-Investigator: Pierre-Yves SALAUN, MD         
Sub-Investigator: Nathalie KEROMNES, MD         
Sub-Investigator: Gael POTARD, MD         
Sub-Investigator: Nathalie ROUDAUT, MD         
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: QUAK Elske, MD    + 33 2 31 45 50 02    e.quak@baclesse.unicancer.fr   
Principal Investigator: QUAK Elske, MD         
Sub-Investigator: BARDET Stephane, MD         
Sub-Investigator: CIAPPUCCINI Renaud, MD         
Sub-Investigator: LASNON Charline, MD         
Sub-Investigator: LASNE-CARDON Audrey, MD         
Sub-Investigator: BABIN Emmanuel, PhD         
Sub-Investigator: BASTIT Vianney, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Fondation de l'Avenir
Layout table for additonal information
Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT04040946    
Other Study ID Numbers: APACH2
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Parathyroid Neoplasms
Hyperparathyroidism
Hyperparathyroidism, Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents