Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Nov 2023 → ongoing

Decision date (initial)

2024-11-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518783-13-00

EudraCT number

2022-002536-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

to assess the vascularity of ileal conduit UD in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit

Secondary objectives 4

1. To assess the feasibility and safety of this technique
2. To evaluate ureteric complications
3. To analyze the effects of fluorescence levels on renal function
4. To assess the oncological outcomes in the study sample

Conditions and MedDRA coding

Patients with gynecological cancers undergoing pelvic exenteration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥18 years, and < 75 years
2. Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed
3. Estimated life expectancy of at least 4 weeks
4. Signed written informed consent

Exclusion criteria 10

1. Hypersensitivity to indocyanine green, to sodium iodide or to iodine
2. Patients affected by hyperthyroidism, or with autoimmune thyroid adenomas
3. Severe kidney failure (eGFR <30ml/min/1,73m2)
4. Patients undergoing only posterior pelvic exenteration
5. Patients undergoing ureterostomy
6. Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive)
7. Refusal to sign written informed consent
8. Any clinical condition, which in the opinion of the investigator, places the subject at risk, prevents the subject from fully participating in the trial procedures, or potentially impairs the quality of the trial data
9. Participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives before the ICG administration, whichever is longer
10. Subjects who are employed by or otherwise dependent on the sponsor or the investigator may not be enrolled in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. the overall rate of benign uretero-enteric stricture

Secondary endpoints 4

1. Rate of Clavien Dindo grade three and four post-operative complications, both early (within 30 days after surgery) and late (from day 31 to day 180 after surgery)
2. To assess the overall rate of ureteric leak in the study sample
3. To assess the differences in eGFR (i.e., renal function) over time (baseline, 1, 3 and 6 months) according to fluorescence levels
4. To assess 12-months overall survival (OS) and progression free survival (PFS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor organisation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Address

Largo Francesco Vito 1

City

Rome

Postcode

00168

Country

Italy

Scientific contact point

Organisation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Contact name

Nicolò Bizzarri

Public contact point

Organisation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Contact name

Nicolò Bizzarri

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications