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Trial registered on ANZCTR


Registration number
ACTRN12619001653156
Ethics application status
Approved
Date submitted
8/08/2019
Date registered
26/11/2019
Date last updated
26/11/2019
Date data sharing statement initially provided
26/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sentinel Lymph Node imaging with hybrid SPECT/CT in patients with cancer of the oesophagus or gastro-oesophageal junction.
Scientific title
Sentinel Lymph Node imaging with hybrid SPECT/CT in patients with cancer of the oesophagus or gastro-oesophageal junction.
Secondary ID [1] 298985 0
NEOSENT2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 313979 0
Condition category
Condition code
Oral and Gastrointestinal 312378 312378 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 313486 313486 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing potentially curative oesophagectomy and lymphadenectomy.

Patients will undergo hybrid SPECT/CT lymphoscintigraphy by means of endoscopically guided intra-tumoral injection of radiocolloid (4 X 0.5 mL in total of 60 MBq 99mTc-nanocoll (GE Healthcare Srl., Milan, Italy). The endocscopy and radiocolloid injection is done by a qualified surgeon with the assistance of a qualified nurse. Patients will undergo this procedure either the day before surgery unless the day of surgery is on a Monday. For logistical reasons, if the surgery is scheduled on a Monday the procedure will instead be done the week before surgery. In the second case, the procedure will be repeated once more on the morning of the day of surgery to allow for intra-operative radio-detection of SLNs.

SPECT imaging is to be performed using a 128 x 128 matrix, 64 projections over 360° and 40 s per projection. Total scan time is 42 minutes. CT scans of the same anatomical region will be obtained with 110 kV, 75mAs and pitch 1.3. Iterative reconstruction of the SPECT data will be carried out with an ordered subset estimation maximation (OSEM) method, four iterations, eight subsets including resolution recovery. A gaussian postfiltration is to be applied with 0.75 cm FWHM.

The images will be reviewed by qualified dual trained radiologists/nuclear medicine physicians. The location of the Sentinel Lymph Node will classified according to the Japanese Classification of Oesohageal Cancer (11th edition). Locations will be kept on record. Sentinel Lymph Node locations will be demonstrated to the operating surgeons immediately before surgery.

Secondly, during surgery (oesophagectomy and lymphadenectomy) the Sentinel Lymph Node will be located intra-operativly by the operating surgeon with the use of a hand held gamma detector. The location of the Sentinel Lymph Node will be kept on record. The Sentinel Lymph Node will be extirpated and labeled accordingly for separate pathological examination. The surgeon will in the same session continue with a lymphadenectomy as part of established clinical routine in this patient group.

These Sentinel Lymph Node biopsies will be examined by a qualified pathologist for signs of metastasis. The findings in the Sentinel Lymph Node will be compared to findings of metastatic disease in the rest of the lymph nodes extirpated as part of established clinical routine in this patient group.
Intervention code [1] 315251 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321011 0
Efficiency of Hybrid SPECT/CT in Sentinel Lymph Node yield in patients with cancer of the oesophagus or gastro-oesophageal junction as assessed by pathological evaluation. Efficiency will be assessed in regard to comparing the rate of successful intraoperative Sentinel Lymph Node localization compared to previous studies where preoperative lymphscintigraphy with planar imaging techniques has been used.
Timepoint [1] 321011 0
At time of definitive pathological asessment of Sentinel Lymph Node biopsy, as well as of all non Sentinel Lymph Node biopsies. 1 week post-surgery.
Secondary outcome [1] 373685 0
Accuracy of Sentinel Lymph Node Biospy in patients with cancer of the oesophagus or gastro-oesophageal junction as assessed by pathological evaluation. Accuracy will be assessed in regard to the sensitivity and specificity of malignant findings in Sentinel Lymph Node biopsies at pathological examination compared to malignant findings in the lymph nodes harvested and examined as part of routine surgical lymphadenectomy.
Timepoint [1] 373685 0
At time of definitive pathological asessment of Sentinel Lymph Node biopsy, as well as of all non Sentinel Lymph Node biopsies. 1 week post-surgery.

Eligibility
Key inclusion criteria
Stage T1–T3, any N-stage, M0 cancer of the oesophagus or gastro-oesophageal junction planned either for direct oesophagectomy with curative intent or for oesophagectomy following neoadjuvant chemotherapy or radio-chemotherapy.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor performance, renal and hematological status

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
2/08/2016
Date of last data collection
Anticipated
Actual
30/08/2016
Sample size
Target
70
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 21755 0
Sweden
State/province [1] 21755 0
Stockholm

Funding & Sponsors
Funding source category [1] 303525 0
Hospital
Name [1] 303525 0
Karolinska University Hospital
Country [1] 303525 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Karolinska University Hospital, Huddinge
SE-141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 303587 0
None
Name [1] 303587 0
None
Address [1] 303587 0
None
Country [1] 303587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304051 0
Regionala Etiknämnden i Stockholm
Ethics committee address [1] 304051 0
Ethics committee country [1] 304051 0
Sweden
Date submitted for ethics approval [1] 304051 0
Approval date [1] 304051 0
07/04/2011
Ethics approval number [1] 304051 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95654 0
Dr Stefan Gabrielson
Address 95654 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 95654 0
Sweden
Phone 95654 0
+46 8 58584642
Fax 95654 0
Email 95654 0
stefan.gabrielson@ki.se
Contact person for public queries
Name 95655 0
Stefan Gabrielson
Address 95655 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 95655 0
Sweden
Phone 95655 0
+46 8 58584642
Fax 95655 0
Email 95655 0
stefan.gabrielson@ki.se
Contact person for scientific queries
Name 95656 0
Stefan Gabrielson
Address 95656 0
FO Medicinsk strålningsfysik & Nuklearmedicin

Karolinska Universitetssjukhuset Huddinge

C2:74, 14186, Stockholm
Country 95656 0
Sweden
Phone 95656 0
+46 8 58584642
Fax 95656 0
Email 95656 0
stefan.gabrielson@ki.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.