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177Lu-DOTATATE for Neuroendocrine Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NYNeuroendocrine Tumors+1 More177Lu-DOTATATE - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether it's safe & effective to give Lutathera directly into the liver artery, compared to the standard approach of intravenous infusion in the arm.

Eligible Conditions
  • Neuroendocrine Tumors
  • Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
177Lu-DOTA-EB-TATE
1
Instylla HES
1
SPI-62 dose1

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 2 years

1 year
Objective response
2 years
number of patients who successfully complete 2 IA injections

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
177Lu-DOTA-EB-TATE
1
Instylla HES
2
SPI-62 dose1

Side Effects for

Octreotide LAR
27%Fatigue
19%Abdominal pain
18%Diarrhoea
13%Abdominal distension
12%Nausea
11%Decreased appetite
10%Back pain
10%Arthralgia
9%Dizziness
9%Hypokalaemia
9%Flushing
9%Oedema peripheral
9%Hyperglycaemia
8%Dyspnoea
8%Vomiting
8%Gamma-glutamyltransferase increased
7%Hypertension
7%Cough
7%Insomnia
7%Anaemia
7%Asthenia
7%Aspartate aminotransferase increased
7%Blood alkaline phosphatase increased
7%Weight decreased
6%Dyspepsia
6%Urinary tract infection
6%Alanine aminotransferase increased
5%Headache
5%Musculoskeletal pain
5%Pain in extremity
5%Anxiety
5%Flatulence
5%Palpitations
5%Constipation
5%Blood creatinine increased
4%Malignant neoplasm progression
4%Hyponatraemia
4%Influenza like illness
3%Haematuria
3%Pyrexia
3%Blood bilirubin increased
2%Abdominal pain lower
2%Syncope
2%Dysgeusia
2%Muscle spasms
2%Alopecia
2%Small intestinal obstruction
2%General physical health deterioration
2%Abdominal pain upper
2%Lymphocyte count decreased
2%Platelet count decreased
1%Cardiac failure congestive
1%Neoplasm progression
1%Anal haemorrhage
1%Dehydration
1%Limb injury
1%Ascites
1%Arteriospasm coronary
1%Pleural effusion
1%Duodenal obstruction
1%Gastrointestinal obstruction
1%Ileus
1%Impaired gastric emptying
1%Malignant bowel obstruction
1%Oesophagitis
1%Generalised oedema
1%Cholecystitis acute
1%Hyperuricaemia
1%Muscular weakness
1%Basal cell carcinoma
1%Breast cancer stage I
1%Carcinoid crisis
1%Non-small cell lung cancer
1%Prostate cancer
1%Haemorrhage intracranial
1%Thrombotic cerebral infarction
1%Transient global amnesia
1%Acute kidney injury
1%Renal impairment
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01578239) in the Octreotide LAR ARM group. Side effects include: Fatigue with 27%, Abdominal pain with 19%, Diarrhoea with 18%, Abdominal distension with 13%, Nausea with 12%.

Trial Design

1 Treatment Group

PRRT with 177Lu-DOTATATE
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: 177Lu-DOTATATE · No Placebo Group · Phase < 1

PRRT with 177Lu-DOTATATE
Drug
Experimental Group · 1 Intervention: 177Lu-DOTATATE · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lutetium Lu 177 dotatate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,846 Previous Clinical Trials
590,058 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
479 Patients Enrolled for Neuroendocrine Tumors
Lisa Bodei, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
9 Patients Enrolled for Neuroendocrine Tumors

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You may have received chemotherapy or other treatments in the past, but it must have been at least 4 weeks ago. If you received treatment before, your disease must have gotten worse since then.

Who else is applying?

What state do they live in?
Idaho100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

Are there any vacancies available for this research endeavor?

"According to the clinicaltrials.gov database, this research effort is presently open for participants and was first announced on September 2nd 2020 with its latest update being January 19th 2022." - Anonymous Online Contributor

Unverified Answer

How many candidates does this trial have capacity for?

"Affirmative, the information hosted on clinicaltrials.gov elucidates that this study is currently recruiting participants; being originally posted on September 2nd 2020 and recently updated on January 19th 2022. A total of 10 enrollees are sought across a single site." - Anonymous Online Contributor

Unverified Answer

Could you provide a summary of prior research undertaken into the efficacy of 177Lu-DOTATATE?

"Currently, 23 active clinical trials are assessing the efficacy of 177Lu-DOTATATE, with one in its final phase. This treatment is being studied by researchers across 162 sites, particularly concentrated in Québec and Iowa." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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